The Danish Parliament has passed a new act implying, among other things, that several products without a medical purpose will in future be subject to the same rules as those governing medical devices. The act will apply as from 26 May 2021.
The Act on research ethics treatment of clinical trials of medical devices, etc., introduces new rules for devices without a medical purpose. The object of the changes is to adapt Danish legislation to new EU rules.
The rules applicable to medical devices do not apply to products without a medical purpose. This follows from the definition of medical devices, and the Danish Medicines Agency did not, as a general rule, have statutory authority to control such products.
EU Regulations on medical devices
The applicable EU directives on medical devices will be replaced by Regulation (EU) 2017/745 on medical devices (MDR) on 26 May 2021 and by Regulation (EU) 2017/746 on medical devices for in vitro diagnostics (IVDR) on 26 May 2022. The objects of the two Regulations are to ensure a high level of health protection and high standards of quality in the EU.
Pursuant to MDR, several products without a medical purpose will be subject to the rules on medical devices in future. The products generally have the same characteristics and risk profiles as medical devices but are currently not covered by any special safety and performance requirements.
The intention of letting the products be subject to MDR is to ensure a high level of protection of patients and users.
Products without a medical purpose
As a result of MDR, several provisions laid down in the Danish Act on Medical Devices (lov om medicinsk udstyr) will also apply to certain specific products without a medical purpose, such as contact lenses without optical strength, fillers, implants and lasers intended for cosmetic treatment.
As far as the said products are concerned, the legal amendment authorises the Minister for Health to lay down rules on:
- Duty of registration for importers and distributors (inclusive of fee)
- Duty of notification and registration for manufacturers and representatives of manufacturers in Denmark marketing or distributing products without a medical purpose in risk classes II a, II b or III
- Supervision and control
- Pharmacy reservations and prescription requirement
- Reporting obligation and duty to inform about relationships between Danish companies and healthcare professionals, etc., (relationship and financial support to participate in health professional activities abroad or international congresses in Denmark)
- Advertising and marketing
In consequence of the new rules, requirements may be made as to registration of importers and distributors of products without a medical purpose by announcement, including, among other things, rules stipulating that the distributor must notify the Danish Medicines Agency of the company's name, address, Central Business Register no. (CVR no.), telephone number, email address, functions as well as data enabling the identification of the types of products imported to or distributed in Denmark by the company as well as changes to such data. The provision also implies that the Danish Medicines Agency will be able to enter the data notified into an electronic register to be used for market surveillance.
According to MDR, importers of medical devices and importers of products without a medical purpose must be registered in the joint European database, EUDAMED. The provision on registration of importers will, however, not apply as from 26 May 2021 as EUDAMED has been delayed. The provision will not apply until six months after the Commission has inserted a notice in the Official Journal of the European Union stating that the database is fully functional. Rules on registration of importers of products without a medical purpose and payment of a registration fee will be repealed once EUDAMED is fully functional and importers must be registered in the joint European database.
For more details on the legal amendments, click here.