From May 26, 2021, the new Medical Device Regulation (MDR) 2017/745 is legally binding. New information has been published on a number of topics.
Standardization: Harmonized standards for the start of validity of the MDR?
Following the positive opinion of the Member States in the Standards Committee (Art. 22) on March 12, 2021, the European Commission will issue a standardization mandate under Regulation (EU) 1025/2012. On this basis, harmonized European standards will be developed by the European standards organizations CEN and CENELEC within the framework of the Medical Devices Regulations. Once their references are published by the Commission in the Official Journal of the European Union, the voluntary application of these harmonized standards confers a presumption of conformity with the requirements of the Regulations (as, for example, under Article 8(1) of MDR 2017/745) that they are intended to cover.
On April 16, 2021, the Medical Device Coordination Group (MDCG) published a guidance document entitled "Guidance on standardization for medical devices." This also describes the revised publication policy of harmonized standards in the context of the ECJ "James Elliott" ruling.
However, according to our information, no single harmonized standards are likely to be published in the EU Official Journal by May 26, 2021. Especially for manufacturers of class 1 medical devices, a difficult situation will thus possibly arise, so that the aspect must be taken into account in the conformity assessment in connection with the technical documentation (Art. 52 (7) in connection with Annex II), since according to Art. 8 (2) the presumption of conformity cannot be applied.
Infographic: Is software a medical device?
The European Commission's Directorate General for Health and Food Safety (DG SANTE) has created an infographic on the decision steps to help qualify medical device software (MDSW).
FAQ: What applies to custom devices?
The Medical Device Coordination Group (MDCG) has published a series of questions and answers about custom devices and considerations for adaptable medical devices and patient-adapted medical devices. The Q&A is a valuable document that aims to answer key questions about custom devices covered by Medical Device Regulation (EU) 2017/745 (MDR).
Feel free to contact our team with specific questions.