Yesterday, the 5th of April 2017, the EU Parliament has announced in its press release that it has adopted two regulations on medical devices and in vitro diagnostic medical devices.
These long-awaited regulations are the result of a process which started in 2012 when the EU Commission submitted two proposals of regulations aiming at replacing the former three directives (90/385, 93/42 and 98/79) on medical devices. This initiative was meant to revise the regulatory framework which had been outpaced by the significant technological and scientific progress over the last decades, especially with respect to the use of software. After years of discussions and compromises between the different Member States, the two regulations on medical devices (MD) and in vitro diagnostic medical devices (IVD) have finally been adopted by the EU Parliament.
These two new regulations are meant to benefit both patients and medical devices manufacturers by ensuring a higher degree of safety, improving access to innovative and cost-effective devices and clarifying the regulatory framework with the aim of facilitating trade between EU countries.
Here is a selection of the important changes that the new regulations include:
Wider scope and clear definitions: the new rules include products intended for the cleaning, disinfection or sterilization of medical devices and also cover implantable or invasive devices without an intended medical purpose such as non-corrective contact lenses, fillers for aesthetic purposes or tattoo removal. The new regulations also clarify the rules applicable to medical software. The scope of the definition of “accessories” is also widened.
Change in classification rules: certain medical devices have to be re-classified and considered as riskier than before, thereby implying a more stringent conformity assessment. New rules have also been introduced for the classification of software and substance-based devices administered via body orifice or applied on skin.
Better identification and traceability of medical devices: the new rules establish a Unique Device Identification (UDI) system in order to enhance the traceability of the devices, facilitate the reporting of serious incidents and allow a quick response in case of safety concerns.
New clinical documentation and clinical investigation requirements: the manufacturer of MD and IVD will have to comply with significant new requirements in terms of clinical assessment of the devices and for certain categories of devices, clinical investigation. The new system will be similar to the requirements already in place within the framework of the Clinical Trials Directive for medicinal products. Manufacturers will have to notify the clinical documentation in European–wide online database (EUDAMED) allowing the public to be adequately informed.
Obligations for the economic actors of the supply chain: the regulations expressly define the role and the obligations of the manufacturers, the authorized representatives, the importers and the distributors of MD and IVD.
Harmonization of the framework of the reprocessing of single-use devices: The regulation on MD provides that reprocessing of single-use devices may only take place subject to the applicable national law and in accordance with the requirements set out in the regulation. The new rules provide for two different regimes depending whether the reprocessor is an independent external actor or whether it is acting within or under the instructions of a health institution, the latter benefits from a less stringent regime. The Member States have been granted the freedom to adopt stricter requirements with respect to the reprocessing of single-use devices.
More powers and obligations for notified bodies: the independent assessment bodies will perform more stringent testing and regular checks on manufacturers, including unannounced factory inspections and sample testing.
Stronger supervision of notified bodies by national authorities: this aims to harmonize the assessment procedure in order to prevent “notified body shopping” (a practice consisting in putting the medical device first on the market of a Member State with less stringent rules, in order to get easy certification and then be able to distribute the product in the EU as a whole);
The industry has been granted a period of three and five years respectively for MD and IVD in order to implement the important changes set out by the new regulations. MD and IVD manufacturers should therefore carefully assess their products portfolio and procedures (including clinical trials planning) in order to prepare for the date of application of the two regulations in 2020 and 2022.