Book a meeting

05 September 2019


(In Danish only)

As part of a new pilot project, the Danish Medicines Agency offers regulatory advice especially for startups and small and medium-sized medical device manufacturers as well as educational and research units. 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.

From 2020, new rules are coming in the EU in the area of medical devices. It covers anything from certain health apps, software and contact lenses to advanced surgical equipment, implants and pacemakers. The rules aim to improve patient safety and ensure the availability of devices that can benefit patients.

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 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.

The advice does not cover approval of products, assessment of specific problems or other matters in which the Danish Medicines Agency can take a decision.

Interested? Companies and others can book a meeting here

Companies and others can request a 1-hour meeting with the Danish Medicines Agency. The meeting can take place at our premises or may be conducted as a teleconference.

Fill in the form to request a meeting with the Danish Medicines Agency and send it to MU-reg.advice@dkma.dk.

We will 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.

Minutes

The company/applicant takes the minutes and sends them to the Danish Medicines Agency at MU-reg.advice@dkma.dk one week after the meeting at the latest. The Danish Medicines Agency will comment on the minutes and approve them officially once agreed.

We will evaluate the concept on an ongoing basis.

The advice of the Danish Medicines Agency is neither binding on the Danish Medicines Agency nor the company/applicant.

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