New concept for regulatory advice on medical devices

28 August 2019

The Danish Medicines Agency has launched a pilot project to offer targeted advice on rules and regulations in the area of medical advices to startups and small and medium-sized medical device manufacturers as well as educational and research units. New rules are under way throughout the EU from 2020.

The Danish Medicines Agency is launching a new pilot project on 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 will initially focus on regulatory guidance in terms of compliance with directives and the coming regulations on medical devices including guidance about requirements and processes regarding applications for clinical investigations in regard to specific products.

The pilot project will run from 15 August 2019 to the end of 2019 and will subsequently be evaluated with a view to its potential continuation. For an initial period, no fees will be charged for the advice.

New rules under way in the EU

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.

An increasing number of medical device companies have sought advice from the Danish Medicines Agency regarding the new EU regulations.

We will evaluate the concept on an ongoing basis.

For more information, please see:

Pilot project on regulatory advice

For more information, please see:

The EU Commission’s information about the new regulations on medical devices

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