CENTRO DI DOCUMENTAZIONE SUI DISPOSITIVI MEDICI

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...

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 an...

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....

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 aforementi...

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

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(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...