Legislation and guidance on medical devices
The Danish Medicines Agency administers the medical devices legislation in Denmark. We also assist in the drawing up of EU rules and guidance documents in the area in relevant European working groups.
As an EU member, Denmark has an obligation to follow the EU rules on medical devices. Medical devices are governed in particular by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.
These regulations are enacted, for example, by the “Danish Act on Medical Devices” and the related executive order on medical devices and in vitro diagnostic medical devices.
The act is a framework act empowering the Danish Minister for Health to lay down the rules necessary for the implementation and application of the medical device legislation of the European Union.
The two regulations are supplemented by the Danish executive order on medical devices and in vitro diagnostics medical devices. The executive order transposes the EU rules on medical devices and in vitro diagnostic medical devices into Danish law. The executive order is supplemented by other legislation applicable to medical devices. The Danish Medicines Agency has gathered the relevant acts, executive orders and circulars pertaining to the medical device area under Legislation.
The legislation changes on an ongoing basis through collaboration between the authorities in the EU, representatives from the industry, scientific societies, patient organisations and more. Guidance in the area is also developed by the European Commission in collaboration with the authorities, scientific societies and industry representatives.
Likewise, the Danish Medicines Agency has prepared a number of guidance documents in the area of medical devices for users, healthcare professionals and medical device companies to assist them with the interpretation of the requirements of the legislation.
Harmonised standards provide methods to document that medical devices conform to the essential requirements of the legislation. The Danish Medicines Agency provides a list of the harmonised standards applicable to medical devices.
General requirements of the law
According to the rules on medical devices, medical devices are required to bear CE marking when marketed. CE marking is the manufacturer’s documentation that the medical device complies with applicable EU legislation.
The medical device legislation contains provisions that must be followed by the manufacturer responsible for marketing the product. The manufacturer must, for example, implement a surveillance system for registration and prevention of incidents and accidents involving medical devices. The manufacturer must gather and deal with experience from the manufacture of the device and from users of the device.
Moreover, manufacturers, authorised representatives and distributors of medical devices and healthcare professionals are obliged to report serious incidents and accidents with medical devices.
The legislation also describes the responsibilities of the authorities in relation to market surveillance. In this connection, the Danish Medicines Agency monitors the Danish market and ensures that incidents and accidents with medical devices are followed up so that causes are investigated and measures can be taken. The Danish Medicines Agency moreover interacts with the European Commission and other authorities and exchanges information on medical devices and safety matters.
The annexes to the EU regulations provide, for example, the general requirements for device safety and performance. The annexes also describe the conformity assessment procedures that manufacturers must follow in connection with marketing of the products. The annexes moreover describe the provisions to be followed by the notified bodies that are responsible for certifying medical devices.