Review of Press Conference on NEW Proposals of European Medical Device Legislation

With over 500,000 medical devices on the European market and the recent PIP fraud incident, amending the current European legal frame work on medical devices was inevitable;

On the 26th of September 2012, Mr. John Dalli, EU Commissioner for Health and Consumer Policy, presented in a 25 minute press conference of September 26th 2012, the main principles within the proposals for new regulations for medical devices and in-vitro diagnostics medical devices adopted by the European Commission.

The revised regulatory framework for medical devices is comprised of 2 proposals:

  • A proposal for a Regulation on medical devices (to replace: Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices);
  • A proposal for a Regulation on in vitro diagnostic medical devices (to replace Directive 98/79/EC regarding in vitro diagnostic medical devices).

The Commission proposals shall be sent at this point for discussion in the European Parliament and in the European Council. They are expected to be adopted in 2014 and would then gradually come into effect from 2015 to 2019.

Obelis’ communication officer listened in to the press conference to provide a summary of the main points in the proposed legislations – presented below by order of introduction:

  • A wider scope in order to eliminate ambiguity on borderline classifications (e.g. aesthetic implants or medical software) but also to provide a stricter legal framework on matters such as internet sales, supervision of Notified Bodies by national authorities, clinical evidence and more.
  • Clarifications on the privileges and responsibilities of the manufacturer, the importer and distributor, the authorized representative, the notified body and the national authorities.
  • Introduction of a UDI (Unique Device Identification) system for better traceability throughout the supply chain with primary aims of reducing medical errors and combating counterfeiting and fraud.
  • Additional empowerment and obligations towards Notified Bodies (testing & sample testing, regular checks including the novelty of unannounced inspections) with a stronger in-market control by the national authorities in conjunction with better coordination amongst EU member states.
  • An emphasis on transparency & analysis with the upgrade of two important elements:
    • The upgrade of the European database on medical devices (Eudamed), not longer aimed only at national authorities, rather, for the first time, open to patients, healthcare professionals and the general public. This comes as an additional upgrade Eudamed, already introduced in May 2011 by Decision 2010/227/EU ) ;
    • The upgrade of the “Scrutiny Mechanism” for a scientific expert’s opinion at pre-certification stage, which was already introduced by Directive 2003/32/EC (recently repealed by Regulation 722/2012) on medical devices utilizing tissues of animal origin to other high risk devices. . This mechanism requires notified bodies to introduce new applications for conformity assessments to an experts committee which will present within 60 days, binding remarks and comments prior to CE certification.

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