Negotiations on the better regulation of Medical Devices and Medical Diagnostics (IVD) in the EU successfully concluded on Wednesday evening, according to EPP Group lead negotiators, Dr Peter Liese MEP and Mairead McGuinness MEP.
"We are delighted that a deal is finally done. Following some deeply worrying scandals, including that of defective PIP breast implants in 2011, action was needed to ensure patient safety."
“The new Regulation is good news for patients, and by tackling fraudulent producers we will strengthen reputable producers of medical devices, an important industry and employer in Europe," said MEP Liese, EPP Group health spokesperson and Rapporteur for Diagnostic Devices, after lengthy, tough negotiations between the European Parliament and Council.
“The new Regulation tackles the gaps in the outdated existing laws with a clear focus on patient safety at every stage of the process from product development, to market placement and surveillance,” added European Parliament Vice-President McGuinness, who led negotiations on the Medical Devices file for the EPP Group.
One key aspect of the agreement is that unannounced inspections will be carried out on producers of Medical Devices after the products are on the market. That’s a crucial point given that the PIP-scandal revealed that the product originally met all requirements. The producer later replaced the high-quality medical silicone with cheap industrial silicone.
Stricter controls will be introduced for Notified Bodies, which will have to employ medically-trained people. Clinical evidence will have to be furnished with Medical Devices. High-risk devices, such as implants or HIV-tests, will undergo additional safety procedures. While an "implant pass" for patients will allow patients and doctors to trace such products.
While controversial, the Parliament maintained the obligation that Member States must inform patients of the consequences of DNA tests, according to MEP Liese: "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."
The compromise agreement further removes unnecessary red-tape, as Dr Liese added: "We do not want to burden the industry with over-regulation. Europe benefits from a very innovative Medical Devices and Medical Diagnostics industry and we want to encourage the further development of devices that can help improve the health and lives of Europeans.”