New Medical Devices laws to ensure patient safety

Final European Parliament approval for new EU laws on the regulation of Medical Devices will strengthen the industry, which employs 25,000 people in Ireland, and ensure patient safety and consumer trust, according to European Parliament Vice-President Mairead McGuinness MEP, a lead negotiator on the new legislation. However, it is of vital importance that the EU and Member States allocate adequate resources to ensure the new rules are fully complied with.

"Over 4 years of intense negotiations has gone into the drafting of the new laws. Today, the European Parliament gave its final approval to the measures aimed at improving patient safety, while also encouraging innovation in the sector to ensure that new developments in medical devices can come to market," MEP McGuinness said in Strasbourg today (Wednesday).

The new Medical Devices Regulation aims to strengthen patient safety with scrutiny of high risk devices and demanding that those charged with approving of products have sufficient expertise to do so. Unannounced inspections by competent authorities of Notified Bodies is also provided for to ensure full compliance.

“Health scandals, such as that involving criminal activity by the French company Poly Implant Prosthèse (PIP) which affected thousands of women in Ireland and across the EU in 2011, have rocked consumer confidence in the industry. However, they also highlighted gaps in the existing laws which date back to the 1990s. This Regulation aims to ensure patient safety, our number one priority, at every stage of the process from product development, to market placement and surveillance.”

Key measures include unannounced inspections on producers of Medical Devices, after the products are on the market. Stricter controls will also 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.

The new laws will also benefit the industry with much-needed certainty and are especially important for Ireland, according to McGuinness: "In Ireland, there are 250 medical technology companies exporting €7.9 billion worth of products annually and employing 25,000 people - the highest number of people working in the industry in any country in Europe, per head of population."

Ensuring that the MedTech industry in Ireland and across Europe can continue to innovate and develop new and better medical devices is essential for the longevity of the sector, for jobs growth and to ultimately improve the quality of our citizen’s lives, McGuinness added.

However, the focus now must be on the proper implementation of the new rules according to the Midlands North West MEP: "It is absolutely essential that this new regulation, which is quite complex, is implemented correctly across the EU. For that to happen, the European Commission must assign adequate resources to monitor its application and Member States also need to ensure their industry complies".