Ready for MDR? Last chance to identify and close gaps in your documentation

Dr. Melanie Mitterreiter, Junior Consultant, Eurofins BioPharma Services Consulting Munich GmbH, MelanieMitterreiter@eurofins.com

The transitional provisions under Regulation (EU) 2017/745 (MDR), which are applicable for legacy devices already marketed under 93/42/EEC (MDD), will cease no later than 26 May, 2024. By this date, technical documentation for these devices must comply with the new requirements in order for the products to maintain CE certification. To close any gaps in technical documentation, Eurofins BioPharma Services Consulting Munich offers a new service that supports manufacturers by performing gap analyses of their entire technical documentation, and provides strategies and/or documentation to close the identified gaps.

Eurofins Consulting Munich further offers more detailed gap analyses regarding the existing documentation on biocompatibility (ISO 10993 series), packaging (ISO 11607 series) and reprocessing (ISO 17664). In addition, Eurofins Consulting Munich’s experts evaluate changes to existing devices in terms of raw materials used, processing or suppliers and their impact on the biological risks of the final devices. Validity of studies conducted under previous versions of biocompatibility standards can also be evaluated. Based on our regulatory expertise, required biocompatibility testing can be reduced through identification of efficiencies resulting in lower costs and reduced time for the overall evaluation of legacy devices.

Besides gap analyses and change assessments for existing devices, Eurofins Consulting Munich also supports medical device manufacturers throughout the complete development of new devices. This includes planning of appropriate testing strategies and the determination of chemical characterisation parameters appropriate for individual devices and their clinical application. The proposed testing strategies are not only based on relevant ISO standards, but also take into account recommendations from a variety of additional guidance documents published by regulatory authorities, for example the US FDA. Corresponding biological evaluation plans, toxicological evaluations of leachable and extractable profiles and biological risk assessments can be prepared for a wide range of different medical devices (e.g. dental products, implants, blood contacting devices).

For more information about medical device documentation and evaluation, visit: www.eurofins.de/medical-device-consulting/