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

LE ISTITUZIONI EUROPEE IN 10 PUNTI - PUBBLICAZIONE GRATUITA

ISBN 979-12-200-1080-1

L’appartenenza all’Unione Europea comporta il rispetto di regole europee che sono gerarchicamente superiori, immediatamente dopo la costituzione repubblicana, alle leggi nazionali.

La gerarchia delle leggi indica i criteri di precedenza da seguire per il rispetto di esse.

Una conoscenza minima di base delle istituzioni europee, dei principi di formazione delle leggi e della loro valenza gerarchica aiutano gli operatori del sistema degli affari regolamentari a comprendere meglio il collocamento delle Direttive e Regolamenti che prescrivono i criteri di sicurezza in ambito marcatura CE nel panorama tecnico-normativo cogente e volontario. 

La pubblicazione scaricabile gratuitamente dal link sottostante, fornisce elementi minimi di base sulle istituzioni europee, sulla gerarchia delle fonti europee e italiane a coloro che non hanno alcuna conoscenza o esperienza in ambito tecnico-normativo.

Un approccio semplice e sintetico per acquisire una base di conoscenza che permetta a chi ha ruoli aziendali di responsabilità di affrontare le questioni del mercato europeo in relazione agli obblighi sui dispositivi medici.

Link download gratuito testo pdf

LE ISTITUZIONI EUROPEE IN 10 PUNTI - PUBBLICAZIONE GRATUITA

ISBN 979-12-200-1080-1

L’appartenenza all’Unione Europea comporta il rispetto di regole europee che sono gerarchicamente superiori, immediatamente dopo la costituzione repubblicana, alle leggi nazionali.

La gerarchia delle leggi indica i criteri di precedenza da seguire per il rispetto di esse.

Una conoscenza minima di base delle istituzioni europee, dei principi di formazione delle leggi e della loro valenza gerarchica aiutano gli operatori del sistema degli affari regolamentari a comprendere meglio il collocamento delle Direttive e Regolamenti che prescrivono i criteri di sicurezza in ambito marcatura CE nel panorama tecnico-normativo cogente e volontario. 

La pubblicazione scaricabile gratuitamente dal link sottostante, fornisce elementi minimi di base sulle istituzioni europee, sulla gerarchia delle fonti europee e italiane a coloro che non hanno alcuna conoscenza o esperienza in ambito tecnico-normativo.

Un approccio semplice e sintetico per acquisire una base di conoscenza che permetta a chi ha ruoli aziendali di responsabilità di affrontare le questioni del mercato europeo in relazione agli obblighi sui dispositivi medici.

Link download gratuito testo pdf

RAPEX - RAPID ALERT SYSTEM FOR DANGEROUS NON-FOOD PRODUCTS - SISTEMA EUROPEO DI ALLERTA RAPIDA PER I PRODOTTI DI CONSUMO PERICOLOSI

The Rapid Alert System for non-food dangerous products facilitates the rapid exchange of information between national authorities of 31 countries and the European Commission on dangerous products found on the market.

The Commission publishes a weekly overview of the alerts on products reported by the national authorities. They include information on the dangerous products found, the risks identified and the measures taken in the notifying country in order to prevent or restrict their marketing or use. Measures can be ordered by national authorities ("compulsory measures") or be taken directly by producers and distributors ("voluntary measures"). Each alert also includes information on the countries where the same product was found and further measures were taken.

Updated to / Aggiornamento al 

18/11/2016

Rapid Alert System – Weekly Notification reports

LINK> REPORT RAPEX

RAPEX - RAPID ALERT SYSTEM FOR DANGEROUS NON-FOOD PRODUCTS - SISTEMA EUROPEO DI ALLERTA RAPIDA PER I PRODOTTI DI CONSUMO PERICOLOSI

The Rapid Alert System for non-food dangerous products facilitates the rapid exchange of information between national authorities of 31 countries and the European Commission on dangerous products found on the market.

The Commission publishes a weekly overview of the alerts on products reported by the national authorities. They include information on the dangerous products found, the risks identified and the measures taken in the notifying country in order to prevent or restrict their marketing or use. Measures can be ordered by national authorities ("compulsory measures") or be taken directly by producers and distributors ("voluntary measures"). Each alert also includes information on the countries where the same product was found and further measures were taken.

Updated to / Aggiornamento al 

11/11/2016

Rapid Alert System – Weekly Notification reports

LINK> REPORT RAPEX

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

NEW PERSONAL PROTECTIVE EQUPMENT REGULATION (EU) 2016/425

As of 21 April 2018, Directive 89/686/EEC will be repealed by the new Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment.

The new PPE Regulation is aligned to the New Legislative Framework policy. In addition it slightly modifies the scope and the risk categorisation of products. It also clarifies the documentary obligations of economic operators.

Entry into force and application 

"This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 

This Regulation shall apply from 21 April 2018, with the exception of: (a) Articles 20 to 36 and Article 44, which shall apply from 21 October 2016; (b) Article 45(1), which shall apply from 21 March 2018. This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Strasbourg, 9 March 2016." 

Go to regolation>Click Here

LE ISTITUZIONI EUROPEE IN 10 PUNTI - PUBBLICAZIONE GRATUITA

ISBN 979-12-200-1080-1

L’appartenenza all’Unione Europea comporta il rispetto di regole europee che sono gerarchicamente superiori, immediatamente dopo la costituzione repubblicana, alle leggi nazionali.

La gerarchia delle leggi indica i criteri di precedenza da seguire per il rispetto di esse.

Una conoscenza minima di base delle istituzioni europee, dei principi di formazione delle leggi e della loro valenza gerarchica aiutano gli operatori del sistema degli affari regolamentari a comprendere meglio il collocamento delle Direttive e Regolamenti che prescrivono i criteri di sicurezza in ambito marcatura CE nel panorama tecnico-normativo cogente e volontario. 

La pubblicazione scaricabile gratuitamente dal link sottostante, fornisce elementi minimi di base sulle istituzioni europee, sulla gerarchia delle fonti europee e italiane a coloro che non hanno alcuna conoscenza o esperienza in ambito tecnico-normativo.

Un approccio semplice e sintetico per acquisire una base di conoscenza che permetta a chi ha ruoli aziendali di responsabilità di affrontare le questioni del mercato europeo in relazione agli obblighi sui dispositivi medici.

Link download gratuito testo pdf

ABC OF THE EU INSTITUTIONS - QUICK SHEET

REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 27 APRIL 2016 ON THE PROTECTION OF NATURAL PERSONS WITH REGARD TO THE PROCESSING OF PERSONAL DATA AND ON THE FREE MOVEMENT OF SUCH DATA

REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance) 

Entry into force and application 

1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 

(published on 4 May 2016)

2. It shall apply from 25 May 2018. 

Go to regulation> Click Here

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - TURKEY

Membership status

Candidate country

Background

In 1987, Turkey applied to join what was then the European Economic Community, and in 1997 it was declared eligible to join the EU.

Turkey's involvement with European integration dates back to 1959 and includes the Ankara Association Agreement (1963) for the progressive establishment of a Customs Union (ultimately set up in 1995).

Accession negotiations started in 2005, but until Turkey agrees to apply theAdditional Protocol of the Ankara Association Agreement to Cyprus, eight negotiation chapters will not be opened and no chapter will be provisionally closed.

Turkey is seeing an unprecedented and continuously increasing influx of people seeking refuge from Syria which has exceeded 2.2 million to date. Overall, Turkey is the country in the world hosting the highest number of refugees, and has already spent more than 7 billion EUR of its own resources on addressing this crisis. The Commission has engaged with Turkey to step up their cooperation on support of Syrians under temporary protection and migration management in a coordinated effort to address the crisis created by the situation in Syria. As a result a Joint EU-Turkey Action Plan was agreed in October and was activated at the EU-Turkey Summit on 29 November 2015. The Action Plan aims at bringing order in the migratory flows and stemming the influx of irregular migration.

On 24 November 2015 the Commission adopted a Commission Decision establishing a Turkey Refugee Facility which will pool 3 billion EUR additional resources. This represents a major additional support and the Facility will coordinate and streamline actions financed from the Union's budget and bilateral contributions from EU Member States in order to enhance the efficiency and complementarity of support provided to refugees and host communities in Turkey. 

Negotiation chapters
Open	Provisionally closed
Free Movement of Capital Company Law Intellectual Property Law Information Society and Media Food Safety, Veterinary & Phytosanitary Policy Taxation Statistics Enterprise & Industrial Policy Trans-European Networks Environment Consumer & Health Protection Financial Control Regional policy & coordination of structural instruments Economic and Monetary Policy	Science and Research

The EU Delegation in Ankara provides more information on Turkey.

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - YUGOSLAV REPUBLIC OF MACEDONIA

Membership status

Candidate country

Background

The former Yugoslav Republic of Macedonia – along with other Western Balkans countries – was identified as a potential candidate for EU membership during the Thessaloniki European Council summit in 2003.

The former Yugoslav Republic of Macedonia applied for EU membership in March 2004. The Commission issued a favourable opinion in November 2005, and the Council decided in December 2005 to grant the country candidate status. In October 2009, the Commission recommended that accession negotiations be opened.

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - SERBIA

Membership status

Candidate country

Background

Serbia – along with 5 other Western Balkans countries – was identified as a potential candidate for EU membership during the Thessaloniki European Council summit in 2003. In 2008, a European partnership for Serbia was adopted, setting out priorities for the country's membership application, and in 2009 Serbia formally applied. In March 2012 Serbia was granted EU candidate status. In September 2013 a Stabilisation and Association Agreement between the EU and Serbia entered into force.

In line with the decision of the European Council in June 2013 to open accession negotiations with Serbia, the Council adopted in December 2013 the negotiating framework and agreed to hold the 1st Intergovernmental Conference with Serbia in January 2014.

On 21 January 2014, the 1st Intergovernmental Conference took place, signaling the formal start of Serbia's accession negotiations.

More information on the country's relations with the EU

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - MONTENEGRO

Membership status

Candidate country

Background

In 2006 Montenegro's parliament declared independence from the State Union of Serbia and Montenegro. In 2008, the new country applied for EU membership.

In 2010, the Commission issued a favourable opinion on Montenegro's application, identifying 7 key priorities that would need to be addressed for negotiations to begin, and the Council granted it candidate status.

In December 2011, the Council launched the accession process with a view to opening negotiations in June 2012.

The accession negotiations with Montenegro started on 29 June 2012.

More information on the country's relations with the EU

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - ALBANIA

Albania

Membership status

Candidate country

Background

Albania – along with other Western Balkans countries – was identified as a potential candidate for EU membership during the Thessaloniki European Council summit in June 2003.

In 2009, Albania submitted its formal application for EU membership. In its Opinion on Albania's application (in 2010), the Commission assessed that before accession negotiations could be formally opened, Albania still had to achieve a necessary degree of compliance with the membership criteria and in particular to meet the 12 key priorities identified in the Opinion.

In October 2012, Commission recommended that Albania be granted EU candidate status, subject to completion of key measures in the areas of judicial and public administration reform and revision of the parliamentary rules of procedures.

In June 2014, Albania was awarded candidate status by the EU.

More information on the country's relations with the EU

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