Regulatory advice for medical device companies
The Danish Medicines Agency offers regulatory advice especially for startups and small and medium-sized medical device companies as well as educational and research units in Denmark. 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 EU regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
What does the advice cover?
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 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.
What does the advice not cover?
The regulatory advice does not cover:
- Classification of devices, including specific advice on risk classification of a specific device.
- Approval of of medical devices.
- Specific assessment of documents that are part of an application for clinical investigations (the Danish Medicines Agency authorizes an application for clinical investigations, which is why the Danish Medicines Agency cannot make a preliminary assessment of the application’s documents. However, we can provide guidance on the general requirements for the application).
- Take a position on specific issues or other matters where the Danish Medicines Agency can make a decision.
- Commercial issues and scientific advice.
- Please note that consultants and other private advisers are not covered by this concept.
Interested? Companies and others can book a meeting here
Companies and others can request a meeting with the Danish Medicines Agency. The meeting can take place at our premises or may be conducted as a teleconference.
We will strive to confirm a meeting date within 14 days.
The advice given is based on the actual knowledge in the area and is not binding on the Danish Medicines Agency and any later decisions in specific cases. Please be advised that we cannot be held responsible for any meeting delays or specific situations where meeting requests cannot be accommodated.
The advice of the Danish Medicines Agency is neither binding on the Danish Medicines Agency nor the company/applicant.