The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”). On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as a Medical Device Change Programme
The EU’s regulatory rules for medical devices are due to change on 26 May 2020, when the new Medical Device Regulation (“MDR”) comes into effect. The regime for in vitro diagnostic devices will change two years later from 26 May 2022 when the In Vitro Diagnostic Devices Regulation (“IVDR”) will apply.
In advance of these changes, the EU Medical Device Coordination Group (“MDCG”) has recently published guidance on the Qualification and Classification of Software in the MDR and IVDR (the “Guidance”).
The aim of the Guidance is to assist manufacturers with interpreting the new Regulations to assess whether their software meets the definition of a medical device or an in vitro diagnostic device (i.e., “qualification”); and if so, what regulatory class the software would fall under (i.e., “classification”).
The MDCG is a coordination group established under Article 103 of the MDR, comprising up to two medical device experts from each EU Member State. Its key functions include contributing to the development of guidance to ensure effective and harmonized implementation of the EU’s new medical device rules. The Guidance is not legally binding nor does it necessarily reflect the official position of the European Commission. However, given the MDCG’s important role in the regulatory landscape, the Guidance is likely to be highly persuasive.…