Updated Information on the Negotiations Concerning the New Medical Device/IVD Regulation

So far, the European Parliament, Council and Commission already agreed on some important proposals, such as the classification and conformity assessment of high risk medical devices (Chapter V). The most recent meeting focussed on the proposals of the Presidency on Scrutiny IVDs, Periodic Safety Update Reports (PSURS) and trendreports on IVD, as well as on a proposal on genetic counselling from the European Parliament.

The following topics are currently being discussed during the Council meetings:

  • IVD Scrutiny proposal: Article 40(21) provides for additional examination of IVDs class D by a European reference laboratory. The European Parliament once again emphasized the importance of additional experts and these reference laboratories. On the other hand, the Council is still undecided and does not consider an additional examination as necessary as high risk devices are already taken into account within the existing provisions.
  • PSURs (Periodic Safety Update Reports) and trend reports: The original Commission and European Parliament proposal claimed trend reporting for medical devices of class III and class IIb for which the manufacturer should report statistically significant increase in frequency and severity of incidents, whereas the Council position was that this should be done for all risk classes. This Council proposal has now finally been accepted by the European Parliament, together with the proposal for classification rules for IVDs. The European Commission indicated to fully support the proposal of the Presidency as being well balanced and providing enough possibility for compromise.

The PSUR-proposal itself, as introduced by the Council and the Parliament, was supported by a majority of Member States. However, it remains to be seen if such a provision should only include a limited scope of only medical devices class III or all classes of devices for both medical devices and IVDs as supported by the Council and the Commission.

  • Genetic counselling: Initiated by the European Parliament, the proposal to introduce genetic counselling is still widely refused by the Member States and the Dutch Presidency stressed that they see no need for a compromise in this respect. Nevertheless, there could be a possible compromise for genetic counselling only within the context of prenatal care.
  • The proposal of the European Commission regarding fees (Art 70) and a suggested delegated act was widely rejected by the Member States voting for a co-decision procedure within the determination of fees.
  • The Council still could not agree on the proposal of introducing an obligatory liability insurance for manufacturers of medical devices
  • Re-use of products: The Council finally adopted the Commission proposal under the condition that the company re-using a product has to ensure full traceability as well as concerned hospitals also have to ensure full traceability as well as to establish a registry for possible problems and to provide patients with sufficient information if treated with such a product.

list of medical devices excluded from re-use still needs to be developed as the European Commission could not so far agree on the proposed compromise by the European Parliament and the Council.

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Published on 11. May 2016 in News EU