Our specialist medical device team work with diverse global companies within the industry to sustain growth, exploit current and future innovations, and secure their business's success. Our clients are multinational corporations and start-ups within the medical devices industry from companies within medical devices or in vitro diagnostic medical devices.
With sector-specific expertise grounded in scientific intelligence and technological know-how, clients value our knowledge of the regulatory frameworks shaping clients' strategic options, the technology being deployed, and our ability to execute complex legal solutions across multi-jurisdictions.
We ensure that our clients operate within the boundaries of medical regulations, data privacy, competition/anti-trust, procurement, pricing and reimbursement, advertising and promotion, and anti-bribery compliance/fraud and abuse laws.
We are pivotal in leveraging growth through strategic alliances, fundraisings, IP and compliant data privacy and security activities, and are relied on to resolve both offensive and defensive cross-jurisdiction patent litigation.
With in-depth sector expertise, we also actively engage with the wider medical devices industry through our connections with esteemed industry bodies and as leading voices in industry publications and wider expert webinar/seminar series.
Eckert & Ziegler Strahlen- und Medizintechnik AG, a German FSE stock listed company on all aspects of a cross-border merger. Eckert & Ziegler Strahlen- und Medizintechnik AG, one of the world's largest suppliers of isotope technology components for radiation therapy and nuclear medicine with headquarters in Berlin, as absorbing entity merged with the Belgian Eckert & Ziegler BEBIG SA, which was listed on the Euronext Brussels stock exchange. The transaction is a rare example of cross-border mergers of two listed companies on the basis of the European harmonized requirements of the EU Company Directive (EU) 2017/1132.
Press releaseHalyard Health on the sale of its surgical and infection prevention (S&IP) business to OMI.
Latest news & insights
Regulatory Update: Microplastics and Medical Devices
Electronic instructions for use for medical devices
Labelling requirements for medical devices under the new EU Product Safety Regulation
Medical device manufacturers: control your supply chain for MDR and IVDR requirements
by Alison Dennis and Paolo Palmigiano
Medical device manufacturers and your Approved Body
What to do in the light of new case law if you consider your notified body has made a wrong decision
by Julian Randall and Alison Dennis
Tools and online services
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.
Our two comprehensive guides provide 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.
MDR Medical Device Checker
Our MDR Medical Device Checker assesses the likelihood of your product falling within the scope of the Medical Devices Regulation.