Placing a pharmaceutical product or medical device on the EU market requires navigating marketing-authorisation procedures, clinical-trial regulations, GMP
Pharma & Medical Device Licenses covers legal assessment, document preparation and implementation support in Europe. It is typically relevant to businesses, investors and organisations operating or transacting in one or more countries. The precise rules, competent authority and procedure depend on the subject matter, jurisdiction and facts, with EU and national law considered together.
The applicable framework depends on the subject of the service, governing law and countries in which the structure or transaction has effect. EU law and current national legislation are assessed together.
Last reviewed: 22 September 2026
Placing a pharmaceutical product or medical device on the EU market requires navigating marketing-authorisation procedures, clinical-trial regulations, GMP compliance, and pharmacovigilance obligations. Regulatory missteps delay market access by months or years. We guide manufacturers, MAH holders, and distributors through the regulatory pathway from development to post-market surveillance.
For pharmaceuticals, we advise on centralised, decentralised, and national marketing-authorisation procedures, clinical-trial notifications under the Clinical Trials Regulation, and pharmacovigilance system master files.
For medical devices, we address conformity-assessment routes under the Medical Devices Regulation, notified-body selection, UDI registration, and the post-market surveillance documentation that keeps products legally on the market.