On June 15, 2016, the European Council’s Permanent Representatives Committee and the European Parliament’s Environmental Committee, supported by the European Commission, endorsed two new regulations on medical devices and in vitro diagnostic (IVD) medical devices. The new regulations – the product of over four years of discussion and negotiation among the Council, the Parliament and the Commission – represent a major overhaul of existing rules in the EU. In many areas, rules will become tighter, requirements stronger and surveillance greater.
The regulatory changes for medical device and IVD device companies are significant and include:
- More pre-market scrutiny: a pre-market assessment mechanism will be applied to certain high-risk devices. The assessment mechanism will be entrusted to an expert panel. This panel will review the Notified Bodies’ initial assessment.
- Increased vigilance and market surveillance: manufacturers will have to report serious incidents and corrective measures to EUDAMED, a European databank on medical devices. Also, the new regulations will require a more active approach to vigilance data collection. Manufacturers of certain classes of devices will have to provide periodic safety update reports (as is already the case for medicinal products). Moreover, manufacturers of high-risk devices will have to provide a summary of information on safety and performance to the Notified Bodies for conformity assessment and make the summary publicly available. The new rules will also tighten regulation and surveillance of Notified Bodies and establish a legal requirement to carry out unannounced inspections.
- Transparency and traceability: devices will be identified and traced using a unique device identification (UDI) system. Also, the new regulations will establish a revised publicly accessible EUDAMED databank containing information on certification of devices, as well as information on clinical investigations, vigilance and post-market surveillance.
- Increased regulation of clinical evidence: requirements for clinical evidence will become stricter and manufacturers of high-risk devices will have to submit a summary of safety and performance supplied with clinical data. Clinical investigation subjects will receive more protection, and the concept of “sponsor” has been introduced.
Following last week’s endorsement of the texts, the Council is expected to officially approve the two regulations in September 2016. Following such approval, it is anticipated that the Parliament will formally adopt the regulations by the end of 2016 or early 2017. Medical device companies will then have three years to adapt to and implement the new rules, while IVD medical device companies will have five years.