IMPLEMENTING THE NEW MEDICAL DEVICES REGULATION: INDUSTRY CALLS FOR SOLUTION TO ENSURE CONTINUITY OF CARE TO PATIENT

MDD REGULATION TRANSITION TIME - STOP THE CLOCK (?)

MedTech Europe -  Original publisher

MedTech Europe is calling on the European Commission, European Parliament and all EU Member States, to have an urgent discussion of solutions that will ensure that there is appropriate time for the systems to be ready to function. The industry calls for:

• Actions to address challenges on the transition timing

Industry envisages at least three options to be explored either alone or in combination:

a) A ‘stop the clock’ mechanism, that freezes the remaining transition time for both regulations until full readiness of the system has been achieved;

b) An extension of the critical dates of 26 May 2020 and 26 May 2022, for all products;

c) An extension of the critical dates of 26 May 2020 and 26 May 2022, for legacy products only.

Options b) and c) would require a specific timeline to be agreed upon.

• Actions to make the ‘grace period’ an effective instrument and overcome the bottlenecks These could include, for example:

a) Extending its scope to include all products and particularly the legacy products;

b) Having a more feasible and flexible timing.

MedTech Europe is ready to cooperate with the EU institutions and all affected stakeholders to identify and deliver an optimal way forward. We urge all concerned parties in the strongest possible terms to act now, in the interest of patients and industry alike.

GO TO POSITION PAPER / POLICY PAPER MEDTECH EUROPE DOCUMENT - Click> Here

MEDICAL DEVICES AND VITRO IN DIAGNOSTIC MEDICAL DEVICES REGULATION The European Parliament is expected to adopt the two regulations in April, after which they will be published in the Official Journal

From

WebSite

The recent scandals related to metal-on-metal artificial hips or faulty silicone breast implants have strengthened the case for modernising current rules for medical devices.

On 7 March 2017, the Council adopted new EU rules improving the safety of medical devices for the benefit of patients while preserving a timely access to innovative healthcare solutions.

The two new EU regulations (MDD & IVDMDD):

-provide a stronger mandate to independent notified bodies in their assessment of medical devices before they can be placed on the market, and strengthen the oversight of these bodies by national authorities; the new rules also ensure that notified bodies meet the same high safety standards throughout the EU; these measures will improve the safety of medical devices;

-improve the availability of clinical data on devices and clearly set out manufacturers' responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; this will allow manufacturers to react quickly in the event of concerns being raised and help them improve their devices continuously on the basis of actual data;

-improve the traceability of medical devices throughout the supply chain to the end-user or patient by using a unique identification number; this will allow fast and effective measures to be taken in the event of safety problems;

-set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; this will enable them to make better informed decisions.

Go to European Council

Council of the European Union web page for more information>Click Here 

GUIDELINES ON MEDICAL DEVICES - CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC – MEDDEV 2.7/1 revision 4 – june 2016

EUROPEAN COMMISSION DG 

Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies 

Health technology and Cosmetics

ABSTRACT

1. Introduction 

Pursuant to 

- section 6a of Annex I to Directive 93/42/EEC (amended by Directive 2007/47/EC) and to 

- section 5a of Annex 1 to Directive 90/385/EEC (amended by Directive 2007/47/EC), 

the demonstration of conformity with Essential Requirements for a medical device must include a clinical evaluation, which is conducted in accordance with Annex X to Directive 93/42/EEC or with Annex 7 to Directive 90/385/EEC. 

This document promotes a common approach to clinical evaluation for medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. 

The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question. Therefore, this guidance is not intended to impose device-specific requirements. 

This document uses the terms "must", "shall", "have to" where these terms are used in the Directives. "Should" is used in other instances. 

2. Scope 

This guide is not legally binding; only the text of the Directives is authentic in law. It is recognised that under given circumstances, for example as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements. Nevertheless, due to the participation of interested parties and of experts from national Competent Authorities, it is anticipated that this guide will be followed within the Member States, thereby supporting uniform application of relevant provisions of EU Directives and common practices.

On certain issues not addressed in the Directives, national legislation may be different from this guide. 

This guide is regularly updated according to regulatory developments. The latest version of the guide should always be used. This version is a complete revision of the previous texts. 

The medical device legislation in Europe is currently being significantly revised. A new Regulation of the European Parliament and of the Council on medical devices will be published, which may result in changes to important concepts or definitions relating to clinical evaluation. Parts or all of this document are likely to be revised. Some contents (such as contents about notified bodies) are likely to be removed and integrated in other series of documents. 

Go to MEDDEV 2.7/1 revision 4 June 2016>ClickHere

EU - MEDICAL DEVICES GUIDANCE

From

website

The European Commission provides a range of guidance documents to assist stakeholders in implementing directives related to medical devices.

Guidance MEDDEVEs

The MEDDEVs promote a common approach to be followed by manufacturers and Notified Bodies that are involved in conformity assessment procedures.

• The MEDDEVs are drafted by authorities charged with safeguarding public health in conjunction with all stakeholders; industry associations, health professionals associations, Notified Bodies and European Standardisation Organisations. This is in accordance with the relevant annexes of the directives
• MEDDEVs are carefully drafted through a consultation process with all interested parties and are subject to a regular updating process
• These documents have particular reference codes and are endorsed at the Medical Devices Expert Group (MDEG) plenary meetings
• The guidelines are not legally binding. However, due to the participation of the aforementioned interested parties and the experts from competent authorities, it is expected that the guidelines be followed, ensuring the uniform application of relevant directive provisions.

Disclaimer: Please note that the amendments introduced by Directive 2007/47/EC or previous amending directives have not yet been incorporated into all MEDDEVs.

List of Guidance MEDDEVs

See below a complete list of all Guidance Meddevs, including links to further information:

	Title
2.1 Scope, field of application, definition	MEDDEV 2.1/1 (18 kB) Definitions of 'medical devices', 'accessory' and 'manufacturer' April 1994
	MEDDEV 2.1/2 rev.2 (14 kB) Field of application of directive 'active implantable medical devices' April 1994
	MEDDEV 2.1/2.1 (12 kB) Treatment of computers used to program implantable pulse generators February 1998
	MEDDEV 2.1/3 rev.3 (183 kB) Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative December 2009
	MEDDEV 2.1/4 (21 kB) Interface with other directives – Medical devices Directive 89/336/EEC relating to electromagnetic compatibility and Directive 89/686/EEC relating to personal protective equipment March 1994 For the relation between the MDD and Directive 89/686/EEC concerning personal protective equipment, please see the Commission services interpretative document of 21 August 2009 (28 kB)
	MEDDEV 2.1/5 (10 kB) Medical devices with a measuring function June 1998
	MEDDEV 2.1/6 (514 kB) Qualification and classification of stand alone software July 2016

2.2 Essential requirements	MEDDEV 2.2/1 rev.1 (16 kB) EMC requirements February 1998
	MEDDEV 2.2/3 rev.3 (17 kB) 'Use by'-date June 1998
	MEDDEV 2.2/4 (38 kB) Conformity assessment of in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products January 2012

2.4 Classification of MD

MEDDEV 2.4/1 rev.9 (759 kB) Classification of medical devices June 2010

2.5 Conformity assessment procedure	General rules
	Quality assurance. Regulatory auditing of quality systems of medical device manufacturers (See document in the GHTF-global harmonization task force)
	MEDDEV 2.5/3 rev.2 (8 kB) Subcontracting quality systems related June 1998
	MEDDEV 2.5/5 rev.3 (7 kB) Translation procedure February 1998
	MEDDEV 2.5/6 rev.1 (9 kB) Homogenous batches (verification of manufacturers' products) February 1998
	Conformity assessment for particular groups of products
	MEDDEV 2.5/7 rev.1 (92 kB) Conformity assessment of breast implants July 1998
	MEDDEV 2.5/9 rev.1 (96 kB) Evaluation of medical devices incorporating products containing natural rubber latex February 2004
	MEDDEV 2.5/10 (80 kB) Guideline for authorised representatives January 2012

2.7 Clinical investigation, clinical evaluation	MEDDEV 2.7/1 rev.4 (631 kB) Clinical evaluation: Guide for manufacturers and notified bodies June 2016 Appendix 1: Clinical evaluation on coronary stents (100 kB) December 2008
	MEDDEV 2.7/2 rev. 2 (412 kB) Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 90/385/EEC and 93/42/EC September 2015
	MEDDEV 2.7/3 rev. 3 (383 kB) Clinical investigations: serious adverse reporting under Directives 90/385/EEC and 93/42/EC - SAE reporting form (27 kB) May 2015 The new SAE reporting form was taken in use by 1 September 2016.
	MEDDEV 2.7/4 (183 kB) Guidelines on clinical investigations: a guide for manufacturers and notified bodies December 2010

2.10 Notified bodies	The documents on designation of notified bodies under the new regulations are in the section above (MDCG documents)​
	MEDDEV 2.10/2 rev.1 (105 kB) Designation and monitoring of notified bodies within the framework of EC directives on medical devices annex 1 (119 kB), annex 2 (14 kB), annex 3 (16 kB), annex 4 (26 kB) April 2001

2.12 Post-Market surveillance

MEDDEV 2.12/1 rev.8 (763 kB) Guidelines on a medical devices vigilance system January 2013 Additional guidance on MEDDEV 2.12/1 rev.8 (855 kB) July 2019 Ⅰ. MEDDEV 2.12/1 rev.8 – Latest Version Forms MEDDEV 2.12 rev. 7 MIR and FSCA are still valid Active PDF forms How to use FSCA and MIR forms (12 kB) Manufacturer incident report - MIR (971 kB) Field safety corrective action - FSCA (1 MB) MIR and FSCA xml files Please note: Some browser plugins are not compatible with PDF forms. If you have problems opening these forms, please save them to your computer and open them from there. Other forms and templates Field safety notice template (195 kB) FSN customer reply (108 kB) FSN distributor/importer reply (103 kB) FSN Q&A (152 kB) Trend report (151 kB) Periodic summary report (192 kB) Ⅱ. Device specific vigilance guidance DSVG Template (22 kB) DSVG 00 (20 kB) Introduction to device specific vigilance guidance DSVG 01 (24 kB) Cardiac ablation vigilance reporting guidance DSVG 02 (26 kB) Coronary stents vigilance reporting guidance DSVG 03 (250 kB) Cardiac implantable electronic devices (CIED) DSVG 04 (219 kB) Breast implants New MIR form* - as from January 2020 New manufacturer incident report (PDF form) New manufacturer incident report for importing XML file* with Adobe Professional The published MIR form is password-protected so it may be necessary to unlock it for specific purposes (e.g. translating the form, implementing it into in-house IT systems). You can request the password for specific authorised uses, which are subject to terms and conditions. New manufacturer incident report XSD file and XSL files (for implementation in manufacturer’ databases) New manufacturer incident report help text Changelog file *If you're a manufacturer and have already adapted your IT system to version 7.1, you may use this version until the end of March 2020.

MEDDEV 2.12/2 rev.2 (228 kB) Post market clinical follow-up studies January 2012

2.13 Transitional period	MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05) August 1998
	As regards the transitional regime of Directive 2007/47/EC see the interpretative document of the Commission's services of 5 June 2009 (35 kB)

2.14 IVD	MEDDEV 2.14/1 rev.2 (76 kB) Borderline and classification issues. A guide for manufacturers and notified bodies January 2012
	MEDDEV 2.14/2 rev.1 (64 kB) Research use only products February 2004
	MEDDEV 2.14/3 rev.1 (80 kB) Supply of instructions for use (IFU) and other information for in-vitro diagnostic (IVD) medical devices January 2007
	Form for the registration of manufacturers and devices in vitro diagnostic medical device directive, article 10 (213 kB) January 2007
	MEDDEV 2.14/4 (114 kB) CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP January 2012

2.15 Other guidance

MEDDEV 2.15 rev.3 (32 kB) Committees/working groups contributing to the implementation of the medical device directives December 2008

MEDICAL DEVICES: COUNCIL GETTING READY FOR TALKS WITH EP

On 19 June 2015, the Council agreed the substance of its negotiating stance on two draft regulations aimed at modernising EU rules on medical devices and in vitro diagnostic medical devices. This is a step towards providing the presidency with a mandate to start talks with the European Parliament with a view to reach an agreement as early as possible.

The two draft regulations on medical devices cover a wide range of products, from sticking plasters to hip replacements, pacemakers and laboratory tests for assessment of medical interventions.  

The main objective of the two draft regulations is to ensure that medical devices are safe. This would be achieved by strengthening the rules on placing devices on the market and tightening surveillance once they are available.

Reed More>Click Here

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

Link> for pdf document

MEDICAL DEVICE IN EU - Information sheet (At 2012)

AUDITS AND ASSESMENTS PERFORMED BY NOTIFIED BODIES IN THE FIELD OF MEDICAL DEVICES - UNANNOUNCED AUDITS

(For unannounced aduits see annex III)

COMMISSION RECOMMENDATION

of 24 September 2013

on the audits and assessments performed by notified bodies in the field of medical devices

(Text with EEA relevance)

(2013/473/EU)

...omississ...

HAS ADOPTED THIS RECOMMENDATION:

1.   PURPOSE

To facilitate the consistent application of the conformity assessment provisions contained in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC, the notified bodies should apply the provisions of this Recommendation when they perform product assessments, quality system assessments and unannounced audits.

By providing general guidelines for such assessments and unannounced audits, this Recommendation should facilitate the work of the notified bodies as well as the Member States’ evaluation thereof. This Recommendation does not create any new rights and obligations. The legal requirements applicable to all types of devices and conformity assessments are set out in the Union legislation on medical devices.

2.   GENERAL GUIDELINES FOR AUDITS AND ASSESSMENTS

The notified bodies should apply the following:

(a)

Where the manufacturer has applied for a design dossier examination or for a type examination (hereinafter jointly referred to as ‘product assessment’), notified bodies should verify the conformity of the device under all product related aspects referred to in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC for detecting any non-compliance of the device and should apply Annex I.

(b)

Where the manufacturer has applied for an assessment of its quality system, notified bodies should verify the conformity of the quality system with the quality-system related requirements contained in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC for detecting non-compliances of the quality system and should apply Annex II.

(c)

To verify the day-to-day compliance with legal obligations, notified bodies should, in addition to the initial, surveillance or renewal audits, visit the manufacturer or, if this is likely to ensure more efficient control, one of its subcontractors in charge of processes which are essential for ensuring compliance with legal requirements (‘critical subcontractor’) or a supplier of crucial components or of the entire devices (both: ‘crucial supplier’) without prior notice (‘unannounced audits’) in accordance with Annex III.

3.   FOLLOW-UP

Member States should draw this Recommendation to the attention of the notified bodies in the field of medical devices and should supervise the practice of notified bodies with respect to this Recommendation. They should evaluate the notified bodies’ readiness to apply this Recommendation and in particular to perform unannounced audits when deciding on designations of bodies and on renewal or withdrawal of designations.

4.   ADDRESSEES

This Recommendation is addressed to the Member States.

Done at Brussels, 24 September 2013.

For the Commission

Neven Mimica

Member of the commission

Link

(1)  OJ L 189, 20.7.1990, p. 17.

(2)  OJ L 169, 12.7.1993, p. 1.

(3)  OJ L 331, 7.12.1998, p. 1.

(4)  OJ L 157, 9.6.2006, p. 24.

(5)  OJ L 212, 9.8.2012, p. 3.

(6)  OJ L 131, 16.5.2002, p. 17.

ANNEX I

Product assessment

1.

Notified bodies should verify if the device is correctly qualified as a medical device and, in particular, whether the manufacturer has assigned a medical purpose to the device. They should furthermore verify the classification of the device and whether the manufacturer has fulfilled the applicable conformity assessment obligations. They should satisfy the obligations of consultation for certain devices that incorporate a substance which, in case used separately, may be considered to be a medicinal product, a human blood derivative or an animal tissue (1).

2.

Notified bodies should verify the compliance of the device with the relevant Essential Requirements set out in Annex 1 to Directive 90/385/EEC, Annex I to Directive 93/42/EEC and Annex I to Directive 98/79/EC and, if applicable, with the essential safety and health requirements (ESHR) set out in Directive 2006/42/EC. In the case of in vitro diagnostic medical devices, where applicable, they should also verify the compliance of the device with the common technical specifications laid down in Decision 2002/364/EC or, when duly justified, with other technical solutions of a level at least equivalent. Where doubts arise, in the framework of a design dossier examination, as to the conformity of a device, notified bodies should carry out or ask for relevant tests of the device.

3.

Notified bodies should examine the requirements regarding design and construction and the ESHR prior to examining the general requirements set out in Part I of Annex 1 to Directive 90/385/EEC, in Part A of Annex I to Directive 93/42/EEC and in Part A of Annex I to Directive 98/79/EC. They should apply special care to examine all the following aspects of the essential requirements: (a) design, manufacture and packaging; (b) labelling on the device, on the packaging for each unit or on the sales packaging and instructions for use.

4.

The examination of the general requirements should ascertain that among others the following requirements have been met: (a) all hazards have been identified; (b) all risks associated with these hazards have been evaluated and have become part of the overall risk-benefit evaluation; (c) all these risks have been reduced as far as possible; (d) all remaining risks have been subject to protection measures; (e) safety principles have been applied in a way that is compatible with the state-of-the art.

5.

For medical devices other than in vitro diagnostic devices, notified bodies should review all relevant preclinical data, the clinical evaluation and the post-market clinical follow-up undertaken or planned by the manufacturer. They should verify that the clinical evaluation is up-to-date. They should assess the need for and the appropriateness of a post-market clinical follow-up plan (2). If no clinical investigation has been undertaken, they should verify that the device type in question and all the different types of risks linked to the device design, its materials, and its use are appropriately assessed by means of scientific literature or other existing clinical data so that no clinical investigation is needed; they should furthermore examine the special justification (3) needed for implantable devices and devices classified within class III according to Annex IX to Directive 93/42/EEC.

6.	In the case of in vitro diagnostic medical devices, notified bodies should review the performance evaluation undertaken by the manufacturer and post-market follow up undertaken or planned by the manufacturer.

7.

Notified bodies should verify all documentation related to the device’s conformity assessment. To that end, they should verify that the technical documentation is correct, consistent, relevant, up-to-date and complete (4) and that it covers all variants and trade names of the device. They should furthermore verify that the manufacturer’s device identification system and its practice of defining which devices belong to the same type ensure that the notified body’s certificates, the manufacturer’s declarations of conformity and the manufacturer’s technical documentations can unequivocally be attributed to the device examined. They should finally verify that the draft declaration of conformity contains all the necessary items.

8.	The notified body should clearly document the conclusions of its assessment and it should be clearly evidenced how the conclusions are taken into account as part of the notified body’s decision making process.

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(1)  See Section 10 of Annex 1, Section 4.3 of Annex 2 and Section 5 of Annex 3 to Directive 90/385/EEC, Section 7.4 of Annex I, Section 4.3 of Annex II and Section 5 of Annex III to Directive 93/42/EEC and Regulation (EU) No 722/2012.

(2)  See Section 1.4 of Annex 7 to Directive 90/385/EEC and Section 1.1c of Annex X to Directive 93/42/EEC.

(3)  See Annex 7 to Directive 90/385/EEC and Annex X to Directive 93/42/EEC.

(4)  To be regarded as complete, a technical documentation should cover with appropriate depth the items listed in the document of the Global Harmonization Task Force ‘Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)’ as well as additional items required by the European legislation or, for in vitro diagnostic medical devices, ‘Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices’ as well as additional items required by the European legislation, see for these documents http://www.imdrf.org/ghtf/ghtf-archives-sg1.asp

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ANNEX II

Quality system assessment

1.

In the case of full quality assurance system, the verification should ascertain that the application of the quality system assures the conformity of the devices (1) with the legal requirements set out in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC. In the case of production or product quality assurance, the verification should ascertain that the application of the quality system ensures the conformity of the devices with the device type (2).

2.

The quality system assessment should include audits on the premises of the manufacturer and, if this is also necessary to ensure efficient control, on those of its critical subcontractors or of its crucial suppliers. Notified bodies should establish a risk-based approach to identify such subcontractors and suppliers and should clearly document this decision process.

3.

Notified bodies should identify which products the manufacturer regards as covered by its application, whether these products fall under Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC and whether there have been changes to these products or to the quality system since the last audit or since the application. Furthermore, notified bodies should identify the post-market information available to them or to the manufacturer, which might need to be taken into account when planning and executing the audit.

4.

For medical devices of Class IIa or IIb, the notified bodies should review the technical documentation on the basis of representative samples with a frequency and depth following established best practices, taking account of the device’s class, risk and novelty. Samples chosen and reviews conducted should be clearly documented and justified. Over the period of certification of the specific quality system (i.e. for a maximum of five years) the sampling plan should be sufficient to ensure that every device category covered by the certificate has been sampled. Where doubts arise as to the conformity of a device, including its documentation, notified bodies should carry out or ask for relevant tests of the device. Where any non-conformity of a device is detected, they should investigate whether elements of the quality system or incorrect application thereof caused the non-conformity. Where a test has been carried out, notified bodies should provide the manufacturer with a test report and with an audit report which highlights in particular the link between quality system deficiencies and detected non-conformities of devices.

5.	Notified bodies should verify whether the quality objectives and the quality manual or procedures developed by the manufacturer are appropriate to ensure the conformity of the devices falling under the application of the manufacturer.

6.

Notified bodies should verify whether the manufacturer’s business organisation is appropriate for ensuring the conformity of the quality system and of the medical devices. In particular, the following aspects should be examined: the organisational structure, the qualification of managerial staff and their organisational authority, the qualification and the training of other staff, the internal auditing, the infrastructure, and the monitoring of the quality system in operation, including with regard to involved third parties such as suppliers or subcontractors.

7.

Notified bodies should verify the existence of an unequivocal product identification system. This system should ensure that the notified body’s certificates, the manufacturer’s declarations of conformity and the manufacturer’s technical documentations can, in conjunction with that system, unequivocally be attributed to certain devices and not to others.

8.

Notified bodies should verify the manufacturer’s procedures with regard to the product documentation. The procedures relating to the product documentation should ensure that all products intended to be placed on the market or put into service are covered by the necessary certificates issued or to be issued by the notified body. The procedures with regard to the product documentation should also ensure that all products intended to be placed on the market or put into service, regardless of their trade name, are covered by the declarations of conformity of the manufacturer and that these are contained in and are compatible with the technical documentation. Notified bodies should verify the correct execution of these procedures by sampling the product documentation of individual devices.

9.

Notified bodies should verify that the manufacturer’s procedures aiming at the fulfilment of procedural legal requirements, in particular with regard to determining the appropriate class and conformity assessment procedure, are up-to-date, complete, consistent and correct. These procedures should take account of the necessity to provide data in order to allow the notified bodies to respect their consultation obligations for certain devices referred to in Section 1 of Annex I.

10.

Notified bodies should verify that the manufacturer’s procedures aiming at the fulfilment of device related legal requirements, are up-to-date, complete, consistent and correct. They should verify that the procedures on the risk management are in conformity with the legal requirements contained in Part I (general requirements) of Annex 1 to Directive 90/385/EEC, in Part I of Annex I to Directive 93/42/EEC and in Part A of Annex I to Directive 98/79/EC and that the procedures cover among others the aspects listed in Section 4 of Annex I to this Recommendation. They should verify the correct execution of these procedures by sampling the product documentation of individual devices.

11.

In case of manufacturers of medical devices other than in vitro diagnostic devices, notified bodies should verify that the manufacturer’s procedures on clinical evaluations and on the post-market clinical follow-up are complete and correct and that these are correctly implemented. To that end, they should examine clinical evaluations and the post-market clinical follow-up for some of the device types covered by the application, applying the principles described in Section 5 of Annex I to this Recommendation. They should verify the correct execution of these procedures by sampling the product documentation of individual devices.

12.

In case of manufacturers of in vitro diagnostic medical devices, notified bodies should verify the manufacturer’s working procedures on performance evaluations, on the identification of certified reference materials or reference measurement procedures to allow for metrological traceability. They should verify the correct execution of these procedures by sampling the product documentation of individual devices.

13.	Notified bodies should verify that the procedures regarding the design and product development, including any change control procedures, are appropriate to ensure the compliance of the devices.

14.

Notified bodies should verify that the manufacturer controls the manufacturing environment and processes so as to ensure the conformity of the devices with the legal requirements. Notified bodies should pay special attention to critical processes such as design control, establishment of material specifications, purchasing and control of incoming material or components, assembling, software validation, sterilisation, batch-release, packaging, and product quality control, regardless of whether they are subcontracted or not.

15.

Notified bodies should verify the manufacturer’s system ensuring traceability of materials and components, from the entry into the manufacturer’s, suppliers’ or subcontractors’ premises to the delivery of the final product. In particular where risks might be caused by the exchange of raw materials, notified bodies should check the coherence between the quantity of produced or purchased crucial raw material or components approved for the design and the quantity of finished products.

16.

Notified bodies should verify that experience gained in the post-production phase, in particular user complaints and vigilance data, is systematically collected and evaluated for the devices covered by the application of the manufacturer and that the necessary improvement of the devices or of their production has been initiated. They should in particular verify that the manufacturer has in place distributor, user or patient related business processes which are suitable for providing information indicating the need for reviewing the design of the device, its manufacturing or the quality system.

17.	Notified bodies should verify that the documentation and records with regard to the quality system and its changes, the procedure of management review, and the respective documentation control are up-to-date, consistent, complete, correct and properly structured.

18.	At each annual surveillance audit, the notified bodies should verify that the manufacturer correctly applies the approved quality management system and the post-market surveillance plan.

19.	The notified body should clearly document the conclusions of its assessment and it should be clearly evidenced how the conclusions are taken into account as part of the notified body’s decision making process.

General advice in case of outsourcing of the production via subcontractors or suppliers

Critical subcontractors or crucial suppliers may be suppliers of suppliers or even suppliers further down the supply chain. Notified bodies should refrain from signing arrangements with manufacturers unless they receive access to all critical subcontractors and crucial suppliers and thus to all sites where the devices or its crucial components are produced, regardless of the length of the contractual chain between the manufacturer and the subcontractor or supplier.

Notified bodies should note that manufacturers:

(a)	have to fulfil their obligations themselves regardless of any partial or total outsourcing of the production via subcontractors or suppliers;

(b)	do not fulfil their obligation to have at their disposal the full technical documentation and/or of a quality system by referring to the technical documentation of a subcontractor or supplier and/or to their quality system;

(c)	should integrate the quality system of critical subcontractors and of crucial suppliers with their quality system;

(d)	need to control the quality of services provided and of components supplied and the quality of production thereof regardless of the length of the contractual chain between the manufacturer and the subcontractor or supplier.

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(1)  See first sentence of Section 3.2 of Annex 2 to Directive 90/385/EEC, first sentence of Section 3.2 of Annex II to Directive 93/42/EEC and first sentence of Section 3.2 of Annex IV to Directive 98/79/EC.

(2)  See first sentence of Section 3.2 of Annex 5 to Directive 90/385/EEC, first sentence of Section 3.2 of Annex V and first sentence of Section 3.2 of Annex VI to Directive 93/42/EEC and first sentence of Section 3.2 of Annex VII to Directive 98/79/EC.

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ANNEX III

Unannounced audits

1.

Notified bodies should carry out unannounced audits at least once every third year. Notified bodies should increase the frequency of unannounced audits if the devices bear a high risk, if the devices of the type in question are frequently non-compliant or if specific information provides reasons to suspect non-conformities of the devices or of their manufacturer. The timing of the unannounced audits should be unpredictable. As a general principle an unannounced audit should not take less than one day and should be executed by at least two auditors.

2.

Notified bodies may, instead of or in addition to visiting the manufacturer, visit one of the premises of the manufacturer’s critical subcontractors or crucial suppliers if this is likely to ensure more efficient control. This applies in particular if the main part of the design development, manufacturing, testing or another crucial process is located with the subcontractor or supplier.

3.

Within the context of such unannounced audits, the notified bodies should check a recently produced adequate sample, preferably a device taken from the ongoing manufacturing process, for its conformity with the technical documentation and with legal requirements. The check of the conformity of the device should include the verification of the traceability of all critical components and materials and of the manufacturer’s traceability system. The check should encompass a file review and, if necessary in order to establish the conformity, a test of the device. To prepare the test, notified bodies should request from the manufacturer all the relevant technical documentation including previous test protocols and results. The test should be undertaken in accordance with the testing procedure defined by the manufacturer in the technical documentation which has to be validated by the notified body. The test may also be performed by the manufacturer, its critical subcontractor or crucial supplier under observation of the notified body.

4.

Notified bodies in charge of product assessment (1) should, in addition to the steps foreseen in Sections 1, 2 and 3, sample devices belonging to at least three different device types and, where the manufacturer produces more than 99 device types, devices belonging to at least every hundredth type at the end of the production chain or in the manufacturer’s warehouse with a view of testing the conformity of the device types. Variants containing a technical difference which might affect safety or performance of the device should be counted as a separate device type. Dimensional size variants should not be regarded as different types unless specific risks are linked to the dimension. These samples should be tested by the notified bodies or by qualified personnel under their observation on their own premises, or on the manufacturer’s premises, or on the premises of the manufacturer’s critical subcontractor or crucial supplier or in external laboratories. Sampling criteria and testing procedures should be defined in advance. In particular if a sampling in the manufacturer’s premises is not possible, notified bodies should take samples from the market, if necessary with support by the competent authorities, or should perform testing on a device installed at a customer location. To prepare the test, notified bodies should request from the manufacturer relevant technical documentation including final batch testing reports, previous test protocols and results.

5.

Notified bodies in charge of verifying the quality system of the manufacturer (2) should, in addition to the steps foreseen in Sections 1, 2 and 3, verify whether the manufacturing activity ongoing at the time of the unannounced audit is in line with the manufacturer’s documentation relevant for the manufacturing activity and that both are in conformity with legal requirements. In addition, these notified bodies should check in more detail at least two critical processes such as design control, establishment of material specifications, purchasing and control of incoming material or components, assembling, sterilisation, batch-release, packaging, or product quality control. Amongst the suitable critical processes, notified bodies should select one which has a high likelihood of non-conformity and one which is particularly safety relevant.

General advice with regard to contractual arrangements between the notified body and the manufacturer for the organisation of unannounced audits

In order to ensure that notified bodies are in a position to perform unannounced audits, some modalities, such as the following ones, should be considered.

Unannounced audits in premises of the manufacturer or its critical subcontractors or crucial suppliers should be foreseen in the contractual arrangements between the notified bodies and the manufacturers. If a visa is needed to visit the country where the manufacturer is located, the contractual arrangements should contain, as an annex, an invitation to visit the manufacturer at any time and an invitation which leaves the date of signature and the date of visit open (to be filled-in by the notified body). The contractual arrangements should also contain, as an annex, similar invitations issued by the critical subcontractors or crucial suppliers.

The contractual arrangements should foresee that the manufacturers continuously inform the notified bodies on the periods when devices falling under the notified bodies’ certificates will not be manufactured. The contractual arrangements should authorise the notified bodies to end the contract as soon as their permanent unannounced access to the premises of the manufacturer or its critical subcontractors or crucial suppliers is no longer assured.

The contractual arrangements should furthermore cover the measures to be taken by notified bodies to ensure the security of their auditors. The contractual arrangements should provide for a financial compensation for the unannounced audits including, where applicable, the device acquisition, its testing and security arrangements.

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(1)  According to Section 2(a) and Annex I to this Recommendation.

(2)  According to Section 2(b) and Annex II to this Recommendation.