When it comes to selling medical devices in Europe, most people assume that CE marking is the manufacturer’s responsibility alone. While it’s true that the manufacturer plays the lead role, distributors are not off the hook.
CE Marking and Supply Chain Responsibilities Read More »
Expanding into the European Union (EU) or the United Kingdom (UK) is a big step for any medical device manufacturer. The markets are highly regulated — and for good reason. Patient safety, product quality, and regulatory compliance are at the core of the EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the UK Medical Device Regulations (UK MDR).
Authorised Representative / Importer for Your Medical Device Read More »
Thank you! The checklist is now ready to download.
