The EU Medical Device Regulation (MDR), which came into full effect in May 2021, has brought in new requirements for drug delivery devices often used for biologic products. These range from pre-filled syringes, auto-injectors and on-body pumps to novel concepts, such as sensors and matrix combinations. An updated EMA Q&A guidance on implementation of the MDR was released in June and the final version of an EMA guideline on quality documentation for MAAs in July.
At the same time, the EU In Vitro Diagnostic Regulation (IVDR) is planned to come into effect in May 2022, bringing extensive changes for review of all IVDs and introducing a dedicated procedure for companion diagnostics at MAA. At the interface of medicines and IVD development clarification is required to facilitate precision medicine. The EMA Regulatory Science Strategy to 2025, European Medicines Regulatory Network Strategy to 2025 and ongoing European Commission Pharmaceutical Strategy all recognize the increasing importance of the convergence of medicines and medical devices for optimizing treatments of the future. New relationships need to be developed with medical device competent authorities and the third party ‘notified bodies’ that form part of the EU regulatory system for medical devices/IVDs.
This session will look at the CMC impact of the rapidly evolving requirements, from the perspective of pharmaceutical industry, national and EMA regulatory agencies, and notified bodies.