Our Medical Devices team has developed two comprehensive guides to provide clarity for medical device and IVD companies.

EU Medical Device Regulation guides

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.

Request MDR guide    Request IDVR guide

Our experts


We are one of the few firms with specialist regulatory capabilities in the medical device arena across Europe. Our in-depth knowledge of regulations and ability to cut through complexity enable us to support ambitious medical device companies' expansion into the EU and UK. We offer comprehensive support that encompasses data protection, advertising, reputation management, product safety and a host of other closely interrelated disciplines that few firms can combine.
酒店与休闲

New Polish Act on medical devices - Part Three

Available in Polish

2022年5月10日
Briefing

作者 Bartosz Świdrak

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酒店与休闲

New Polish Act on medical devices - Part Two

Available in Polish

2022年4月27日
Briefing

作者 Bartosz Świdrak

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酒店与休闲

New Polish Act on medical devices

Available in Polish

2022年4月20日
Quick read

作者 Bartosz Świdrak

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Interface 2021年10月

'Femtech' and issues around digital health products

作者

5 观点

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