On 22 February 2022, the U.S. Food and Drug Administration (FDA or the Agency) announced that it was issuing a proposed rule to align the Agency’s current Good Manufacturing Practice (GMP) requirements for medical devices, codified at 21 C.F.R. Part 820 and known as the Quality System Regulation, with the international consensus standard ISO 13485:2016 (the ISO). This reflects a years-long effort by the Agency to better harmonise the U.S. requirements with that of many foreign regulators. For example, in the European Union, the ISO is listed in the EU legislation, meaning that a medical device that conforms to this standard is presumed to be in conformity with the EU regulatory requirements on quality management systems for medical devices. This harmonisation should, therefore, provide some consistency between jurisdictions and enable companies to streamline their processes between countries.
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EU Medical Devices Regulation: Adoption of further guidance documents
By Jackie Mulryne, Louise Strom & Eftychia Sideri on
In this post, updating our series of posts on the implementation of the EU Medical Devices Regulation (MDR), we take a look at the latest steps taken by the EU institutions to ensure the MDR is fully applicable by May 2021.
Despite the summer break and the difficulties caused by the pandemic, the Medical Device Coordination Group (MDCG) and the European Commission have endorsed a number of significant guidance documents relevant for manufacturers, national authorities, notified bodies and expert panels. In addition, the fourth implementing act, required by the MDR, has been adopted by the European Commission.
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