On-going negotiations on the Medical Devices Regulation
On 5 October the Council reached a general approach (Regulation – Annexes) on the draft regulation aimed at modernising the European regulatory framework on medical devices.
The medical devices package has been discussed for almost three years. As a reaction to the scandal on breast implants and the problems with some metal hip replacements, in 2012 the European Commission presented two proposals to update the regulations on medical devices and in vitro medical devices. After almost three years of discussions, the 28 EU Ministers finally agreed on a compromise text.
A major step towards the adoption of the regulation happened already last June, with the finalisation of a partial general approach, meaning that the Ministers agreed the substance of the negotiating stance without finding a common position on the recitals. Afterwards the Working Party on Pharmaceutical and Medical Devices of the Council met several times in order to reach an agreement at technical level on those missing parts and few weeks ago a qualified majority voted in favour of the positions developed by Member States’ experts, with the sole exception of the German delegation.
The position of the Council focuses on:
- strengthening the rules on producers’ responsibilities and on clinical investigation in order to increase the availability of reliable data on medical devices;
- tightening the procedures for the designation of notified bodies and for the monitoring of their activities;
- setting up an EU portal where to report incidents by manufacturers and a central EU database for producers and importers.
The Council’s adoption of a general approach allowed the Presidency of the Council to start the so called trilogue negotiations. The trilogue is an informal tripartite meeting between representatives of the European Commission, the Council and the European Parliament with the purpose to get an agreement on the text acceptable to all. Any agreement in trilogues is informal and will have to be approved according to the formal procedures applicable within each of the institutions. The Luxembourg Presidency of the Council scheduled six trilogues and some other technical meetings between now and the Christmas holidays with the intention to reach an agreement by the end of the year.
Two trilogues already took place. The discussions occurred during these first inter-institutional meetings highlighted two main issues:
- the pre-market scrutiny of devices and
- the re-processing of single use devices.
Especially with regard to the last element, the representatives of the European Parliament made it clear that there should be harmonised rules throughout the EU, according to them the European Commission shall prepare a list of devices not subject to re-use, while all the others can be considerate re-processable. Nevertheless there are also other aspects of the regulations that need to be further discussed and where negotiations will not be easy, such as clinical evidence and hazardous substances.
The proposal follows the ordinary legislative procedure, therefore both the Council and the Parliament decide as co-legislators.
If the trilogue goes well and they find a compromise by the end of the year, then the text can become law in the first half of 2016 under the Dutch Presidency.
Any questions? Please contact: Fabian Raddatz
Practice Group: Healthcare, Regulatory & Governmental Affairs
Further articles: Update on EU Regulations on Medical Devices; Revision of the EU Medical Devices Legislation – state of play; Progress on the revised Medical Devices Regulation; Medical Devices Regulation - Trialogues to start soon