The Danish Parliament has passed a new act, which, among other things, moves the authority to process applications on the testing of medical devices and products without a medical purpose. The rules apply as from 26 May 2021.
The new Act on research ethics treatment of clinical trials of medical devices, etc., entails changes in the area for the processing of applications on the testing of medical devices and products without a medical purpose. The object of the changes is to adapt Danish legislation to new EU rules.
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 object of the two regulations is to ensure a high level of health protection and high standards of quality in the EU.
Clinical testing of medical devices presently requires permission from the Danish Medicines Agency and the relevant research ethics committee. The research ethics assessment is thus governed by the Danish Scientific Ethics Committees Act (komitéloven). An application to conduct a clinical trial must be submitted to the regional committee in the area where the party responsible for the trial operates. The committee must reach its decision on whether to approve a project within 60 days of receipt of the application. In some cases, this deadline may be extended, e.g. if the application is incomplete.
According to Danish practice until now, research projects involving products without a medical purpose have not been covered by the Scientific Ethics Committees Act. In consequence, no requirements were made for notification to and approval from a research ethics committee before such research projects were started.
New rules applicable to research ethics assessments of clinical trials
The MDR contains rules on the assessment and approval of clinical trials of invasive devices in classes 11a, 11b as well as devices in class III. According to the MDR this is subject to the approval from the national relevant authority, just as the Regulation stipulates requirements in respect of the applied procedure and time limits. Consequently, the processing no longer takes place according to the rules of the Scientific Ethics Committees Act.
According to the new rules in the MDR, future clinical trials may be conducted only if an ethics committee has not rendered a negative statement against the project in connection with the clinical trial. Furthermore, the new rules entail shorter time limits. In future, clinical trials may be commenced 45-65 days after the validation date, which is 10-15 days at the latest after the date of receipt of the application. The application must be submitted digitally.
It is expected that rules will be laid down pursuant to the Bill on continuation of the requirement for approval of clinical trials of medical devices in class I, and non-invasive devices in classes IIa and IIb, as well as a new requirement for the approval of clinical trials of products without a medical purposes in the same classes of risk, except for the testing of devices with CE labels for the purpose in question.
Moving of the authority to assess clinical trials
In order to meet the new stricter requirements, it has been determined that the research ethics assessment of clinical trials should no longer be conducted by the regional committees. The assessment must instead be conducted by two newly established state research ethics medical committees.
Out of consideration for, in particular, the shortened deadlines, a research ethics committee will only consist of eight members in order for the committee members to be able to meet and conduct a joint assessment before expiry of the applicable deadlines.
The state committees will be assisted by a single secretariat, which according to the Ministry of Health will contribute to effective cooperation between the committee system and the Danish Medicines Agency. The object is to ensure speedier and uniform processing.
It should be noted that the state medical committees are also to effect the research ethics assessment of clinical trials of medicinal products when the regulation on clinical trials applies. Other research projects in the health area will still be processed by the regional research ethics committees.
Clinical trials regarding the performance of medical devices for in vitro diagnostics are not covered by the bill. The IVDR will not become generally applicable until 26 May 2022, for which reason the Ministry of Health will defer its assessment of whether a need exists to amend the law applicable until then.
For more details on the legal amendments, click here.