Plans for stricter monitoring and certification procedures to ensure full compliance and traceability of medical devices such as breast or hip implants were informally agreed between MEPs and the Dutch Presidency of the Council on Wednesday. MEPs also secured tightened up information and ethical requirements for diagnostic medical devices used for example in pregnancy or DNA testing.
"I'm delighted that we finally have an agreement on this key legislation, which will allow us to put in place high standards for the manufacture, authorisation and placing on the market of medical devices." said Public health committee president Giovanni La Via (EPP, IT). "I would like to thank the Parliament delegation, the Dutch Presidency and the European Commission for their efforts and for this satisfactory agreement" he added.
Stronger notified bodies and post-market surveillance
"Patients want to be confident that the devices used to treat them, or even implanted in them, are safe and effective and we have agreed a number of measures to give them this confidence” said rapporteur on medical devices Glenis Willmott (S&D, UK).
“These include stricter requirements for notified bodies, aesthetic devices covered for the first time and a Unique Device Identification system so we know which device has been implanted in which patient. We've also agreed a much stronger system of post-market surveillance so that any unexpected problems are identified and dealt with as soon as possible" she said.
"Pre-market scrutiny of high risk devices was a priority for the Parliament so I'm particularly pleased that we successfully pushed for this and that these devices will now undergo additional assessment from expert panels" she concluded.
Drawing the lessons from the PIP breast implant scandal
“I am very happy that we finally got it done. People in Europe have a right that we draw consequences from scandals such as the scandal on defective breast implants” said rapporteur on in vitro diagnostic medical devices Peter Liese (EPP, DE). “Problems occurred in other areas too, e.g. on stents, that are implanted into the brain, or an unsafe HIV-test. The new regulation is good for patients, puts an end to fraudulent and shady producers and thereby strengthens also respectable producers” he added.
Ethical requirements for DNA testing
Member States will be obliged to inform patients about the consequences of DNA tests. For a long time the last point has been controversial, but there will still be such an obligation for Member States. "DNA-tests can have severe consequences for the life of patients and they should not be carried out without proper information and counselling. Member States pointed out that this is first of all their responsibility and that they will therefore accept European rules only to a certain limit. It is important that Member States meet their obligation. We will be very vigilant on this question", says Peter Liese.
The agreement provides for the following points:
- Random inspections on the producers after devices have been brought out on 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 safety of their products, especially in the case of higher risk classes.
The European Commission published the proposal in 2012, and the European Parliament already agreed on its position three years ago. However, the Member States could only agree on a position in autumn of last year before negotiations with MEPs could start.
Both report will be put to a vote in the Public health committee in June.