MDCG offers guidance on clinical investigations in Eudamed’s absence
The European Commission’s Medical Device Coordination Group (MDCG) this week issued guidance providing a set of templates that will be used to fulfill the application/notification submission requirements for clinical investigations under the Medical Device Regulation (MDR) prior to the availability of the Eudamed clinical investigations and performance studies module.Under MDR, sponsors of clinical investigations for medical devices are required to submit an application/notification to the member state(s) in which the clinical investigation will be conducted, along with the documentation specified in Chapter II of Annex XV of Regulation (EU) 2017/745 using the electronic system referred to in Article 73 of the regulation.
However, with Eudamed delayed and most of its modules still outstanding, MDCG has prepared a set of documents to support the clinical investigation procedures under MDR, which takes effect next week. (RELATED: Eudamed’s delay and its impact on clinical investigations under the EU MDR, Regulatory Focus 8 April 2020; EC sets timeline for rolling out Eudamed modules, Regulatory Focus 14 May 2020; Eudamed launched with actor registration module live, Regulatory Focus 1 December 2020).
The templates include the clinical investigation application/notification form; addendums for additional investigational device(s), additional comparator device(s) and additional investigation site(s); clinical investigation supporting documents; and a checklist of general safety and performance requirements, standards, common specifications and scientific advice.
MDCG notes that the data fields in the application/notification form mostly overlap with those being developed for the Eudamed clinical investigation module.
The release of the guidance and templates follows the issuance of MDCG’s guidance on harmonized administrative practices and alternative technical solutions in Eudamed’s absence earlier this year. (RELATED: MDCG issues guidance on Eudamed alternatives, Regulatory Focus 1 March 2021).
“These documents are intended to be facilitative and their use by the Competent Authorities and sponsors is encouraged, however it is important to check with the individual Member State in which the clinical investigation is planned to be conducted as to any specific national requirements,” MDCG writes in the guidance.
MDCG also says that the templates are anticipated to be withdrawn when the Eudamed clinical investigations module is fully functional.
MDCG