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
Retailer obligations under scrutiny: ECJ to clarify scope of inspection obligations
EU and medicines supply issues (part one): Current measures
Marketing Authorisation Holders (MAHs) in the EU are legally required to report medicine supply shortages to the European Medicines Agency and national authorities. This article explores the central role of Marketing Authorisation Holders (MAHs) in identifying and managing medicine supply shortages in the EU as well as the role of EMA committees and working groups in coordinating responses and maintaining the Critical Medicines List to safeguard public health.
2 / 5 观点
EU and medicines supply issues (part two): Proposals for future measures
In part two of our article on EU and medicine supply issues we explore the key proposals outlined in pharmaceutical reform and their impact on marketing authorisation holders across the region.
3 / 5 观点
Guidance to manufacturers withdrawing a medical device from the EU market
Medical product availability and healthcare safety are becoming increasingly important talking points. This is also reflected in the EU regulations on medical devices. Although the provisions may seem straightforward their vagueness may give rise to significant doubts as to which situations they will apply to in practice.
4 / 5 观点
Europe's approach to supply chain issues for medicines and medical devices
5 观点
