Medical Devices Revision

The Luxembourg Presidency is going to conclude its semester without reaching an agreement on the medical devices proposal. The 5th and last trilogue of December 3 did not bring the desired outcome, therefore the dossier will pass on the incoming Presidency. The Netherlands will be the 8th delegation working on the revision.

At the end of December, Luxembourg will conclude its term as President of the Council. Twelve meetings of the Council Working Party on Pharmaceuticals and Medical Devices and five trilogues – the informal tripartite meetings among representatives of the European Commission, the Council and the European Parliament – between July and December have not been enough for the negotiators to conclude the discussions on the proposal for a revision of the medical devices legislation. The Netherlands will take over from Luxembourg the dossier; the 6th inter-institutional meeting between the Council and the European Parliament is expected already for the end of January or at the latest the beginning of February. The negotiators hope to find an agreement by the end of June 2016.

The European Commission presented its proposal for a regulation in September 2012. Following Parliament’s 1st reading in April 2014, the Council agreed its position last October (Regulation – Annexes) allowing for inter-institutional negotiations to start. Trilogue meetings took place on 13 and 28 October, on 11 and 28 November and on 3 December. Discussions on all chapters have been launched; it being understood that “nothing is agreed until everything is agreed”, there is an emerging agreement on chapters I (scope), II (obligations of economic operators) - except for article 15 (reprocessing) - and chapter III (identification and traceability). At the last trilogue of December 3, the negotiators held discussions on chapters IV (notified bodies), V section II (conformity assessment), VII (surveillance of the market), VIII (cooperation between Member States) and the related annexes. With regard the assessment procedure for the high-risk devices, the negotiators of the European Parliament presented a compromise text to the Council. In the previous trilogues of November, the representatives of Council, Parliament and Commission exchanged views on chapters V section I (classification rules - in particular article 41) and X (transitional measures).

During the negotiations it has always been stressed the need to find the right balance between patient safety and innovation. In addition to that, many Member States constantly expressed concerns about some specific elements of the proposal, such as the reprocessing of medical devices for single use, clinical investigations, the scrutiny procedures for high-risk devices and post-market surveillance. Many delegations also raised the problem of the increase of administrative burdens. The legislation is complex and highly technical; it has been debated for over three years and there are still divergences between the different positions of the Council and the Parliament. But it is mainly inside the Council that the text has been discussed and opposed. As of January it will be the turn of the Netherlands to try to find a compromise on the text.

The current EU legal framework for medical devices was harmonised in the 1990s and consists of the Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices. Having regard to the technological and scientific progress occurred in the last years and, above all, after the breast implants scandal of 2010, the European Commission decided to review the existing rules. The main focus of the proposal is on the pre-market scrutiny and post-market surveillance of devices and on their traceability along the supply chain.

 

Further reading: On-going negotiations on the Medical Devices Regulation; Federal Court of Justice (also) rules on product liability for medical devices exhibiting an increased risk of failure; Medical Devices Regulation - Trialogues to start soon