Update On Overhaul of EU Medical Device Regime

Global Life Sciences: EU Update

An important step in the European Union’s review of the two proposed regulations intended to replace the current three directives that form the EU regulatory framework for medical devices is scheduled to take place on 10 July 2013: the European Parliament’s responsible committee on the environment, public health and food safety (“ENVI”) is set to vote on the proposed regulations and the more than 1300 tabled amendments.

The scheduled vote follows extensive discussions and stakeholder activity since our previous background note on the proposed regulations (available here). The debate on the proposals flared up in particular when the ENVI committee’s rapporteur on the proposal for a medical device regulation (“MD Rapporteur”) proposed to introduce a pre-market authorization system for high-risk medical devices, and to classify all medical devices as “reusable” unless the manufacturer can, inter alia, justify based on scientific evidence that the devices cannot be reprocessed safely (the MD Rapporteur’s draft report is available here).

The ENVI committee’s rapporteur on the proposed regulation on in vitro diagnostic medical devices (“IVD Rapporteur”) took a different position and generally supported the overall regulatory approach proposed by the European Commission. The IVD Rapporteur focused more on elements deemed to be in the interest of patient protection and social aspects, including in particular the possible impact of diagnostic results on a patient’s future. With those interests in mind, the IVD Rapporteur, for example, proposed stricter requirements for genetic testing and self-tests, including with respect to informed consent and possible mandatory counseling for patients (the IVD Rapporteur’s draft report is available here).

Although the IVD Rapporteur did not propose a pre-market authorization system for high-risk IVDs, the MD Rapporteur tabled over 120 amendments to the proposed IVD regulation, including amendments introducing a pre-market authorization system for high-risk IVDs.

The ENVI committee debated the two proposals and all tabled amendments on 29 May 2013. During the meeting, it became clear that there is considerable opposition to the introduction of a pre-market authorization system for medical devices and IVDs. Several Members of the European Parliament spoke out against a pre-market authorization system, and the European Commission reiterated that its impact assessment had led it to reject the inclusion of such a system in its original proposals.

Which direction the ENVI committee will take will remain uncertain until after the vote scheduled for 10 July 2013. After the ENVI committee vote, the full European Parliament and the Council of the EU will also have to adopt the proposed regulations with any ENVI committee amendments, and significant additional amendments may still be introduced by EU Member States. The European Parliament is currently scheduled to vote on the proposed regulations on 9 September 2013, while the Council of the EU is expected to vote on the proposed regulations prior to the European Parliament elections in May 2014.

If adopted, the proposed regulations are expected to become applicable, respectively, three (medical devices) and five (IVDs) years after their adoption, although selected provisions directed at the European Commission, the competent authorities of EU Member States and conformity assessment (or “notified”) bodies will likely become applicable sooner.

If you have any questions regarding this update, please contact the Sidley lawyer with whom you usually work.

The EU Life Sciences Practice of Sidley Austin LLP

Sidley’s EU Life Sciences practice assists multinational companies and trade associations with food, pharmaceutical, biotechnology, medical device, cosmetics and dietary supplement issues in the European Union. Our lawyers offer strategic advice for gaining and maintaining market access. We anticipate government actions, advise on approval and submission strategies, and interface with trade associations, consultants and governmental officials. Clients turn to our group for assistance with compliance issues relating to Good Manufacturing Practice, EU Drug Safety/Pharmacovigilance, and Quality System regulations, as well as EU competition and trade law issues.

For further information on the EU Life Sciences Practice, please contact:

Maurits J.F. Lugard


mlugard@sidley.comMaarten Meulenbelt


mmeulenbelt@sidley.comMike W. J. Beckers



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