EU Regulation of Medical Devices; the Changes Continue

October 8, 2013

Regulation of medical devices in the EU continues to evolve following the Poly Implant Prothèse (PIP) breast implants scandal.

The latest changes, announced by the European Commission (EC) on 24 September 2013, are: an EC Implementation Regulation clarifying the criteria to be met by “notified bodies”; and a Recommendation clarifying the tasks these bodies have to undertake when they perform audits and assessments in the sector. Notified bodies are organisations or companies designated by the EU Member States to carry out control of manufacturers of medium- and high-risk medical devices. There are about 80 notified bodies for medical devices in the EU.

These actions were taken under the existing legislative framework and are some of the immediate measures which the EC requested the Member States agree to its February 2012 call for immediate action to protect patients after the PIP scandal.

Of most immediate interest to any medical device company selling in the EU is the Recommendation, since, amongst other things, it provides for “a clearer basis for unannounced audits”. These audits will be factory audits of certain manufacturers which must be carried out at least once every three years (including outside the EU).

The products in question are the very wide range of products under the responsibility of the notified bodies in the EU. Broadly, the products covered are therefore:

  • a range of general medical devices, including: medium- to low-risk products such as tracheal tubes and dental filling material; medium- to high-risk products such as X-ray machines, bone plates and screws; and high-risk products such as heart valves, total hip replacements and breast implants;
  • all active implantable medical devices, such as pacemakers and implantable defibrillators;
  • certain in vitro diagnostic medical devices, including certain reagents, reagent products and devices for self-testing.

Manufacturers of these products in particular should consider their response.

More significant changes are anyway on the horizon. The February 2012 call for immediate action was followed by two draft regulations proposed by the EC in September 2012. These regulations, which would replace the entirety of the existing basic legislation regarding sales of medical devices and in vitro diagnostic medical devices in the EU, continue to wend their way through the legislative process. When announcing the September 2013 documents, the EC Commissioner in charge commented that “[f]ull clarity can only be achieved through amending the basic legislation. I am committed to support the [European] Parliament and the [EU] Council with a view to completing the on-going revision by early [2014]”.

The original EC proposals of September 2012, were voted on and amended by a European Parliament Committee on 25 September 2013. Amongst other things, the Committee’s amendments would change the original proposals by boosting public access to clinical data, creating a new approach to labelling medical devices and creating a new advisory body of experts. The notified bodies would also be beefed-up and would provide closer scrutiny of manufacturers’ own product safety tests. On the in vitro side, the Committee voted for involvement of an ethics committee and introduced provisions on informed consent and genetic counselling.

Both draft laws are due to be put to a vote by the full European Parliament during the 21 to 24 October 2013 session.