The implementation of the EU Medical Device Regulation (MDR) and the EU In-Vitro Diagnostic Regulation (IVDR) is fast approaching, arriving in May 2021 and May 2022 respectively. Medical device and IVD companies face considerable changes to the regulatory framework for their products and need to plan ahead to ensure that they are ready.
These regulations will have a far-reaching impact upon any business seeking to expand into the EU. However, the sheer complexity of the regulations and the volume of continuous new guidance in relation to them creates serious barriers to market entry.
Our Medical Devices team has developed two comprehensive guides to help address this. Each guide provides clarity for medical device and IVD companies who may find the sheer size and complexity of the regulations a substantial hurdle to their international expansion plans.
Latest medical devices news and insights
Katie Chandler recognised in The Lawyer's Hot 100 2024
par Shane Gleghorn et Katie Chandler
Higher Administrative Court of Münster: Subsequent authorization of a homeopathic medicinal product
Artificial Intelligence (AI) in medical devices: The better the product, the harder the conformity assessment?
Updated post-market surveillance (PMS) rules for medical devices in the UK: differences from the EU regulations
par Alison Dennis et Alice Matthews
Legal requirements for green claims in advertising for medical devices
par Dr. Daniel Tietjen et Sherin Sayed