Vesna Janic

Proposed EU Medical Device Regulations

On September 26, 2012 the EU Commission released its proposal for future medical device regulation. The current Directives (active implantable medical devices (AIMD), medical devices (MDD) and in vitro diagnostic medical devices (IVDD)) will be replaced with two Regulations (one for medical devices and the other for IVDD).

The changes are long overdue. This revision of the Regulations was initiated in 2008 after the discovery of industrial silicone in breast implants created a scandal that caught the public’s attention. The new rules should improve traceability and transparency, harmonize  current requirements between AIMD, MDD and IVDD Directives, facilitate more uniform interpretation of Regulations by Member States, and improve overall patient safety in EU.

In the best case scenario, the EU Parliament will accept the changes without too much debate, meaning the final draft will be finished by March 2014. Once the final agreed text is published in the Online Journal of the EU, the legislation will then gradually come into force with a final transition timeline of three years (MDD) and five years (IVD) post publication (OJEU).

Here are some of the proposed changes:

  • The MDD and IVDD will become a Regulation rather than a Directive
  • Stronger supervision of Notified Bodies by National Authorities
  • More powers for Notified Bodies, including unannounced factory inspections at manufacturing sites
  • Clarified responsibilities for manufacturers, authorized representatives, importers and distributors, including in the case of diagnostic services and internet sales
  • Extended database on medical devices (Eudamed), providing comprehensive and public information on products available on the EU market
  • Creation of a Medical Device Coordination Group (MDCG) composed of national competent authorities’ representatives to ensure better coordination between Member States, with the Commission providing the necessary scientific, technical and logistic support
  • The Notified Body will have to inform the MDCG of all new high risk applications and submit a summary of safety and performance of MDD and Class D IVDD and the MDCG can request additional information within 15 days and additional information within 90 days (this does not apply to changes to existing products)
  • Reinforced requirement for clinical data for the pre-market and the continuous post-market assessment of medical devices, including in-vitro diagnostic medical devices
  • Adaptation of the general health and safety requirements, including labeling provisions, to the technological and scientific progress
  • Each manufacturer and authorized representative will require a Qualified Person with 5 years field specific regulatory experience to be responsible for the conformity of batches to be released, maintenance for the technical documentation and declaration of conformity plus vigilance reporting

For better understanding of specific MDD and IVDD requirements, I would recommend review of the actual proposal.

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