The new regulation on medical devices has now entered into force - what does that entail?

Manufacturers

Among other things, manufacturers should note that the regulation entails that clinical investigations of medical devices for human subjects will be subject to more stringent rules. Further, the obligations in relation to following-up on the quality, performance and safety of a device will be stricter for the manufacturers. The manufacturers should also note that notified bodies now have the right and are under obligation to carry out unannounced inspections of the manufacturers’ premises. Article 10 of the regulation lists the other general obligations of the manufacturers.

The general obligations of the different economic operators

The new regulation defines other operators as authorised representatives, importers and distributors (or collectively “economic operators”). Articles 11-14 of the regulation stipulate the obligations of the individual operators. It is worth noting that going forward, all operators will be subject to obligations regarding monitoring, notification and documentation in relation to the devices themselves, but also in relation to the corresponding supply chain. To a larger extent than before, the individual operators must now verify whether the devices in question have been marked with/are accompanied by the required information. 

For distributors in particular, it is worth noting that the distributor concept comprises all operators in the supply chain other than the manufacturer or the importer that makes a device available on the market, up until the point of putting it into service. This means that the distributor is not exempt from its obligations just because another company, also defined as a distributor, has already met the relevant requirements.   

Unique Device Identifiers (UDI)

The new regulation also requires medical devices to carry unique device identifiers (UDI) to facilitate their traceability throughout the supply chain from the manufacturer to the patient. The starting point being that the manufacturer is responsible for placing the UDI on the device. However, the importer and the distributor both have to verify that the UDI has been placed on/accompanies the device. UDIs will be introduced gradually for devices in the various classes, which means that UDIs are not required for all devices from the outset. 

Registers

According to the new regulation, it is also a requirement that companies keep a register of complaints, of non-conforming devices and of recalls and withdrawals. 

If a company repackages and/or relabels devices, the company must also ensure through a quality management system i) that the translated information on labels and instructions for use is correct and updated; ii) that changes to the outer packaging, including a change of pack size, are carried out in such conditions that the original condition of the device cannot be affected by it; and iii) that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system must cover procedures ensuring information about any corrective action taken by the manufacturer. The system must be certified by a notified body designated for certifying the devices in question and the activities performed. Article 16(3) of the regulation describes the quality management system.

EUDAMED

Similarly, the central European database on medical devices, EUDAMED, will be updated pursuant to the regulation, so as to contain information on manufacturers, notified bodies, clinical investigations, certificates, damage caused by medical devices and fault conditions/failures in medical devices, among other things. Manufacturers (except for manufacturers making custom-made devices), authorised representatives and importers must all register with the database. However, manufacturers of custom-made devices, distributors and specialist shops must still be registered with the Danish Medicines Agency. 

The various EUDAMED modules will become operational continuously, and therefore it is not required that all information is reported as from 26 May 2021.

The sale of devices conforming to previous legislation 

For a period, it will still be possible to market medical devices conforming with the requirements stipulated in previous legislation. Accordingly, any medical devices still in the supply chain which have not reached the end-user may continue to be made available on the market until 27 May 2025. After this date, the medical devices must be recalled.

However, certificates issued by notified bodies in accordance with the directives in force at the time will only remain valid until the end of the period indicated on the certificate, or until 27 May 2024, whichever comes first. After 27 May 2024, certificates issued in accordance with the directives become void, and it will only be possible to sell the associated products if said products have already been brought into circulation on the European market.  

Plesner will continue to keep an eye on the interpretation of the obligations under the new regulation. Please contact us if you need advice on what the new regulation means for your company, and how you ensure that you comply with the new requirements.

Read the new regulation on medical devices.