Medical Devices, In Vitro Diagnostics and Eudamed

Medical Devices, In Vitro Diagnostics and Eudamed

Two new regulation for Medical Devices and In Vitro Diagnostics (IVDs), which will apply from 2020, mandate that devices will become fully traceable and that key product information must be given to patients. An expansion of the European Databank on Medical Devices (Eudamed) is also planned to improve data quality, interlinkage and transparency. The medical devices regulation introduces changes including stricter rules for reprocessing of single-use devices. The main changes are:

Quality, safety and reliability of medical devices: The new rules expand the definition of a medical device and will cover certain, previously unregulated aesthetic products (e.g. coloured contact lenses that do not correct vision). Tighter controls will be imposed on clinical trials together with the introduction of special notified bodies for high-risk devices such as implants. A new system for risk classification in line with international guidelines will apply to in vitro diagnostic medical devices.

Transparency of information for consumers: The new regulations will ensure information accessibility. For instance, patients will receive an implant card with all the essential information, and a unique device identifier will be mandatory for every product.

Vigilance and market surveillance: EU countries will coordinate more closely in the field of market surveillance with enhanced post-market oversight powers for notified bodies including unannounced audits. Manufacturers will be obliged to collect data about the performance of any product from its entry to the market with a requirement to monitor and act promptly if emergencies arise.

Access to the Eudamed repository (currently only for competent authorities and the European Commission) will expand to include market participants including notified bodies, Medical Device Coordination Groups, economic operators (manufacturers, authorized representatives, etc), non-European market regulators, and public entities (medical institutions, press organizations, etc).
Data will include information as to where in Europe devices have been distributed and which parties are responsible for the products in addition to:

• Unique device identification (UDI) data
• Single registration numbers for all economic operators
• Accreditation and designation data for notified bodies
• More vigilance and post-market surveillance data
• Notified body conformity assessment applications
• Safety and clinical performance summaries for medical devices and IVDs
Apart from new classification rules and stricter requirements for re-using single use devices, specific rules for software as a medical device are introduced, accounting for the significant developments in this area in the past 20 years. In addition, a pre-market scrutiny procedure is introduced for certain types of high-risk devices.

EC Press Release
EP Press Release

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