With the revision of the regulatory framework for medical devices in Europe, the Medical Device Regulation (MDR) is also introducing new requirements with high impact on medicinal products with integral medical devices. In this regards, the European Medicines Agency (EMA) recently released a Question and Answer (Q&A) document to provide guidance concerning the interpretation and implementation of these requirements.
But there are still open and unclarified questions, which the EMA Q&A document is not covering. It is unclear, for example, which aspects of the technical file of the device constituent part are expected to be submitted. Especially for parts of the product documentation which are not clearly drug or device constituent, like Transport Validation, Assembly and Packaging or the Process Validation documents. Are they also expected to be reviewed by the Notified Body?
Johann Delchmann (B.Eng.) - one of our Medical Device Specialists - was so kind to dip into this extensive Q&A document. Within his White Paper he summarizes the EMA Q&A document on the one hand and tries to point out obscure issues which are still open on the other hand (klick HERE to download).