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.
Latest news & insights
The EU MDR transition times extension explained
IVDR extended transition period: What it means for IVD manufacturers
The CJEU: The recurring question of the separation of medicinal products and medical devices
by Dr. Manja Epping and Sherin Sayed
Article 97 derogations – help for manufacturers waiting for their MDR certificates
To be, or not to be (a medical device): when does software qualify as a medical device?
Tasmina Goraya, PhD
Dr. Manja Epping
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.