Europe: New Medical Device Regulation: Stricter Controls, no Central Granting of Authorisations

The European Parliament ("Parliament") voted on the proposals tabled by the EU Commission (the "Commission") for a new medical device regulation on 22 October 2013. Many of the Commission's proposals - relating to traceability, reprocessing and tighter controls - were accepted. The installation of a central European authority tasked with the granting of authorisations was not, however, deemed necessary by either the Commission or Parliament.

The Commission Proposal

The Commission tabled drafts of a new medical device regulation and a new in-vitro diagnostic medical device regulation intended to replace the existing medical device directives (90/385/EEC, 93/42/ECC and 98/79/EC) on 26 September 2012. In contrast to the currently applicable directives, the regulations are designed to be directly applicable to Member States and do therefore not require to be implemented by way of special legislation by each of the Member States. In terms of the new regulations, the Commission will, at least in part, assume a monitoring role - a function that has to date been a purely national matter.

Better Controls in relation to Medical Implants

The Parliament adopted the proposals of the Commission for tighter controls in relation to medical devices and medical device manufacturers on 22 October 2013. In future, inspection bodies will, in particular, have to show that they have sufficient medical expertise to inspect the devices in question. The inspection bodies will also have to conduct unannounced inspections and verify the conformity of end products and raw materials. Inspection bodies assessing high risk devices (e.g. implants) will in future be directly selected and monitored by the European Medicines Agency (EMA) in London.

The Commission reserves the right to assess high risk devices through a newly created committee and, if necessary, to refuse market authorisation to such devices. In this respect, the current authority and competence of national inspection bodies will be reduced. The Parliament does not, however, intend to introduce a central "super authority" along the lines of the American FDA, as this would unreasonably increase the bureaucratic burden on medical device manufacturers.

The purpose of the planned regulation is to harmonise existing differences. It is intended that medical device manufacturers from countries, which have sometimes had a competitive advantage in the past vis-à-vis, for example, German medical device manufacturers, due to fewer inspections being conducted in such countries, will now be equally well controlled. This is good news for German manufacturers of medical devices, who are already subject to high standards of assessment and quality in Germany.

Traceability

A system for the traceability of medical devices and an implant passport is to be introduced. This will enable patients to be better informed about devices concerning them, and will ensure that manufacturers can contact patients in the event of problems with their devices.

Single-use Medical Devices

The draft regulation makes provision for persons and institutions reprocessing single-use medical devices to be held liable for their re-use (e.g. disinfected forceps). The Commission will also be authorised to compile a list of products that may not be reprocessed.

Conclusion

There is currently no unanimity as yet in the position of the European Council (in which all Member states are represented) on the proposed regulation. A number of MEPs are demanding that the new regulations should be adopted before the European elections in May 2014 - whether this is feasible, remains to be seen.

Hendrik Thies, Jan Henning Martens

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