Negotiations between the European Parliament, European Council and European Commission to agree on the proposed revision of the EU medical devices legislation have begun last week. In the so called ‘trilogue’ negotiations the three groups will seek to reach an agreement on a finalised text.
The new legislation will take the form of two EU Regulations, one on medical devices and one on in vitro diagnostic medical devices, and will replace the current three Directives concerning these products.
At the recent Association of British Healthcare Industries (ABHI) Regulatory Conference 2015, representatives of industry, commentators and regulatory bodies took the opportunity to discuss specific features and provisions contained in the negotiating positions put forward by each of the EU institutions. MedTech Europe, the association for the medical device industry in Europe, in particular, outlined what industry hopes will be the outcomes of the negotiations.
The negotiations will be conducted in a series of five blocks that will each deal with specific parts of the Regulations. Interspersed between the political trilogue meetings will be technical meetings.
Trilogue 1 took place on 13 October 2015, dealing with Chapters 1 and 2 of the proposed Regulations. These negotiations were anticipated to progress reasonably smoothly and to allow some common ground to be built before some of the more contentious matters are dealt with in the later trilogue meetings. It is notable for example that negotiations relating to reprocessing of single use devices, were excluded from this set of negotiations, despite forming part of Chapter 2. The reprocessing provisions contained in the Council’s approach were described by MedTech Europe as being inconsistent, as they will effectively result in three different levels of safety standards being applicable to a device depending on whether it has been reprocessed and by whom.
The provisions on reprocessing will be dealt with in the second set of trilogue negotiations, which are scheduled to start on either 26 or 29 October 2015. This block will also cover the European database on medical devices (Eudamed) and Unique Device Identification, the system for improving transparency and traceability; clinical investigations; and Chapter IX, which covers confidentiality, data protection, funding, and penalties.
Trilogue 3, scheduled to begin 10 November 2015, will focus on issues specific to IVDs.
Trilogue 4 will begin on 18 November and will deal with another of the more controversial aspects of the proposed Regulations, in the form of the provisions relating to scrutiny and Notified Bodies. While MedTech Europe welcomed the increased oversight of Notified Bodies, it expressed concern at the provisions relating to scrutiny. Those proposals would see the establishment of a new body that would have the power to scrutinise the pre-market assessment undertaken by Notified Bodies of certain high-risk devices. MedTech Europe was of the view that this system would be redundant, as it would provide an extra layer of complexity without improving patient safety.
The fifth and final set of trilogue negotiations is intended to iron out any areas where agreement could not be reached in the preceding trilogues. This is scheduled to begin on 5 December 2015.
Ultimately, the European Parliament does have a right of veto over new legislation. However, if the outcomes of the trilogue negotiations are successful, the agreed text will likely receive a rapid second reading in the European Parliament, with a view to adoption in early 2016.
Adoption of the Regulations will then initiate an expected three to five year transitional period for the implementation of the Regulations.