As part of a new pilot project, the Danish Medicines Agency is offering regulatory advice especially for startups and small and medium sized medical device manufacturers as well as educational and research units. As the agency explains:
“We are offering one-to-one meetings to help them get off on the right foot. We offer these meetings in response to an increasing demand from medical device companies for regulatory advice on the new EU regulations.
The concept for our regulatory advice is specifically aimed at startups and small and medium-sized medical device manufacturers as well as educational and research units. It is possible to request a meeting with the Danish Medicines Agency to obtain more detailed guidance on the applicable and coming rules, including the coming EU regulations on medical devices, as well as guidance about requirements and processes regarding applications for clinical investigations in regard to specific products as well as general regulations about CE marking.”
Access to the system, presumably only for Danish manufacturers, is available from here.