On 25 May 2016, the final trilogue discussions took place concerning the new Medical Devices/In-vitro Diagnostics (IVD) Regulation. Finally, the European Parliament and the Council agreed on a set of new rules for these products although the European Commission still does not agree with all of the compromises but will have to position itself soon regarding this compromise.
Currently, the Council’s secretariat is drafting the consolidated version of the regulations which can take up to ten days. The consolidated version is foreseen to be presented and approved on 15 June in the Committee of the Permanent Representations and on 16 June in the ENVI Committee of the European Parliament. A formal vote is expected later on this year. Transitional periods for three (Medical Devices) and five years (IVD) are foreseen.
Edith Schippers, Minister of Health of the Netherlands and President of the Council stated: “This agreement matters to all citizens: sooner or later all of us enter into contact with medical devices to diagnose, prevent, treat or alleviate diseases. The deal reached will improve patients’ health and it will help to enhance the quality of life of disabled persons. It will also ensure a level playing field for the 25.000 medical devices manufacturers in the EU, many of which are SMEs and which employ more than half a million persons.”
In detail, the final agreement provides for the following points:
- Random inspections on the manufacturers after devices have been released to the market
- Notified bodies will be controlled in a stricter way and will have to employ medically skilled people
- For high risk devices, such as implants or HIV-tests, an additional safety procedure is introduced; not only a notified body, but also a special committee of experts will control if all requirements are met
- An “implant card”for patients is introduced, enabling patients and doctors to track which product has been implanted
- Like for medicines, medical devices manufacturers will have to provide clinical evidence of the safetyof their products, especially in the case of higher risk classes
Some of the topics have been discussed on controversially until the end of the trilogue, namely:
- Re-use of products:the agreement finally states that it is the competence of Member States to decide on the reprocessing of medical devices. However, this has to be subject to strict safety standards.
- The claim of the European Parliament for genetic counselling: the final decisions contains an obligation for Member States to inform patients about the consequences of DNA testing but leaves the definition of the counselling itself up to the Member States.
- IVD Scrutiny: Article 40(21) provides for additional examination of IVDs class D by a European reference laboratory, which has been rejected until now by the Member States. The concluded compromise foresees that these reference laboratories have to be established as second control stage for high risk IVDs.