Statens legemiddelverk, the Norwegian Medicines Agency, issued an official notice to warn all parties involved in operations with medical devices that have been delayed in the launch of the new European database – EUDAMED.
EUDAMED is a database designed to store information on all medical devices available on the EU market in a structured and accessible way. It is also a platform for information exchange among national regulating authorities, notified bodies, industry representatives and the general public. The database will be composed of several modules and the first module is expected to be launched in March 2020. The European Commission’s legal advisors stated that the partial launch of the database is not compliant with the requirements set forth by the Medical Device Regulation 2017/745 (MDR) and In Vitro Medical Diagnostic device Regulation 2017/746 (IVDR). They stated that EUDAMED should be fully functional before being launched. Thus, EUDAMED would be less likely to be launched earlier than May 2020.
During the period of time in which EUDAMED is unavailable, certain requirements contained in the MDR and IVDR will be not applicable while the appropriate requirements set forth in Medical Devices Directives should be applied instead.
Potential Impact of the Implementation Delay
The authority describes in detail exactly how the delay in launching EUDAMED will impact relations in the sphere of medical devices.
- Individual Registration Number (SRN). According to the MDR and IVDR, the manufacturers, their authorized representatives and importers of medical devices should be assigned with the individual registration number (SRN) via EUDAMED.
- Unique device identifiers (UDI). The new rules provide that all medical devices should have special marks allowing the identification and tracking of such devices. These requirements would be applicable and binding for all of the parties irrespectively from the launch of EUDAMED.
- Registration of manufacturers and devices. Norwegian medical device manufacturers, as well as duly appointed authorized representatives of foreign medical device manufacturers should register in the Norwegian national register. This requirement would be applicable until registration through EUDAMED becomes possible.
- Safety notices. Before the launch of EUDAMED, all corrective action reports, adverse events reports and information on any identified defects of medical devices should still be submitted to the national regulating authority. The Norwegian medicines agency also notifies that the new incident reporting form (MIR) becomes obligatory from January 1, 2020, irrespectively of whether the particular device is being supplied under the new rules based on Regulations or under the Directives and the framework existing previously.
- Clinical trials. Any clinical trials should be held in accordance with the requirements set forth by the MDR from May 26, 2020, despite the actual delay in launching the EUDAMED. However, the EUDAMED could not be used as a means of communication, so the European Commission is actively developing guidance on ways to solve this issue.
Certain Aspects of Medical Devices Registration in Norway
Norwegian medical device manufacturers and their authorized representatives should duly register their medical devices in the appropriate registers. At the same time, the distributors of medical devices fall outside of the scope of these requirements and do not have to register their equipment. The authority highlights the following key points of the registration rules:
- The manufacturer is responsible for updating the information contained in the register in a timely manner to keep it accurate and up-to-date,
- To be able to use the register, the manufacturer shall create an account by filling in the information requested. The name of the user and the password would be submitted via email specified when registering,
- For the purpose of this, the scope of parties that must register medical devices in the register includes: a) the Norwegian manufacturer as a natural or legal person responsible for design, manufacturing, packaging and labeling of the medical device intended to be supplied in its behalf irrespectively of whether the whole scope of work is performed by the manufacturer itself or by any other third party on his behalf, b) the Norwegian manufacturer of the custom made medical devices, c) authorized representatives constituting any natural or legal person established within the EEA and explicitly designated by the manufacturer placed outside the EEA, acting on behalf of the manufacturer and representing it in all communications with the governmental authorities and agencies within the EEA regarding the obligations of the manufacturer of medical devices, d) any natural or legal person manufacturing devices with a CE mark.
- The registration should be finished before marketing the devices, meaning that the declaration of conformity should be issued prior to the registration of the device.
- The manufacturer also has a right to register the device during the development stage.
- If the regulating authority would identify that the obligations on the registration were not duly performed, it is entitled to issue a special order requiring to perform the registration.
It is also provided that it is allowed to make medical devices available on the Norwegian market on the basis of Manufacturing and Importation Authorisation (MIA) or a Wholesaler Distribution Authorisation (WDA). To use such an approach, the medical device manufacturer should notify the Norwegian Medicines Authority in advance. At the same time, such a procedure could be applied only by the entities holding the appropriate authorisations issued by the National Competent Authorities of other EU member states while the authorisation issued by the Norwegian authority does not allow its holder to use this approach.
The Norwegian Medicines Agency actively collaborates with the European authorities and the European Commission to find solutions to deal with the issues related to the delay in launching EUDAMED. The authority informs that it would notify the industry representatives and all the parties involved on the updates and provide them with additional recommendations on dealing with the consequences of the delay. The authority also sends out the informational guidelines on medical devices regulation to assist manufacturers in maintaining compliance with applicable requirements.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.