The Danish parliament has adopted new legislation supplementing the Danish rules on post-market surveillance of medical devices. The rules will apply as from 26 May 2021.
The new Danish Act on research ethics treatment of clinical trials of medical devices, etc., introduces changes in the rules governing the marketing of medical devices in Denmark. The object of the amendment is to adapt Danish legislation under Regulation 2017/745 on medical devices (MDR) and Regulation 2017/746 on medical devices for in vitro diagnostics (IVDR). This article offers a brief review of the changes, which come into force on 26 May 2021.
Obligation to store invoices to be discontinued
Under applicable law, importers and distributors of medical devices must save copies of all invoices relating to medical devices that they have sold and delivered to the Danish market for five years as from the date of delivery of the device. The same obligation applies for 15 years to implantable devices sold and delivered to the Danish market. Further, the Danish Medicines Agency may request a copy of these invoices as part of its market surveillance of medical devices.
MDR and IVDR include rules on traceability, including requirements to distributors and importers, that allow identification of recipients and suppliers of devices in the supply chain.
As a result of the amended national requirements, importers and distributors will no longer have to save copies of invoices, and accordingly the Danish Medicines Agency can no longer request copies of such invoices.
Companies’ obligation to report incidents directly to the Danish Medicines Agency to be discontinued (over time)
Under applicable law, manufacturers of medical devices or their representatives as well as importers or distributors of medical devices must immediately file a report with the Danish Medicines Agency of any malfunctioning, failure or deterioration of the characteristics or performance of a medical device as well as any inaccuracy in the labelling or instructions for use of which the relevant person has become aware and which may cause or may have caused the death of a patient or user or serious deterioration of the health of a patient or a user.
Under the Executive Orders, the manufacturer or representative is also obligated to report to the Danish Medicines Agency as soon as possible of any technical or medical feature in the characteristics or performance of a medical device that has caused the manufacturer's systematic withdrawal from the market of medical devices that belong to the same category of devices. Applicable law provides the Danish Medicines Agency with the statutory basis for setting out rules on the formal requirements to such notification.
The amendment extends the general statutory basis of the existing duty to report incidents so that such requirement may be imposed also on operations managers of public and private hospitals, authorised healthcare professionals outside the hospital service, and others who use medical devices as part of their profession.
However, as MDR and IVDR include particular rules on the duty of manufacturers, their authorised representatives, importers and distributors to report incidents with medical devices, the Danish statutory requirement for such parties to report to the Danish Medicines Agency cannot be maintained when the regulations are implemented into Danish law.
In the travaux preparatoires to the bill, the Danish Ministry of Health notes that a duty to report will still apply to manufacturers as well as to importers and distributors of medical devices for in vitro diagnostics after 26 May 2021.
Manufacturers' duty to report to the Danish Medicines Agency may apply for six months after the EU Commission has announced that the joint European database for medical devices (EUDAMED) is operational. Then the rules of the regulation on manufacturers' duty to report incidents, reports on results of investigations of incidents and safety-related corrective measures will apply directly, so that manufacturers must report through EUDAMED to the competent authorities.
The duty of importers and distributors of medical devices for in vitro diagnostics to report incidents is expected to be maintained until 26 May 2022 when the duty to report under IVDR will apply.