[Introduction]
Article 61(4) of Regulation (EU) 2017/745 on medical devices (MDR) requires clinical investigations to be performed for implantable and class III devices, except in four specific cases as outlined in:
CASE 1) indents 1-3 of Article 61(4);
CASE 2) Article 61(6)(a);
CASE 3) Article 61(6)(b);
CASE 4) Article 61(5).
These four cases which are exempted from the requirement to perform clinical investigations are independent of each other; i.e. the criteria outlined in one paragraph do not apply to the other paragraphs unless directly referenced.
One important consequence of this independence of cases is that the requirement for a contract, pursuant to Article 61(5), does not apply to the cases outlined in indents 1- 3 of Article 61(4), Article 61(6)(a) and Article 61(6)(b). For these cases, it is only necessary to demonstrate equivalence in accordance with the criteria listed in Annex XIV Section 3 MDR to be able to use the associated clinical data in the clinical evaluation.
In addition to outlining the technical, biological and clinical characteristics to be taken into consideration for the demonstration of equivalence, Annex XIV Section 3 mandates that “It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence”. The requirement to have sufficient levels of access to the data required to establish equivalence does not in itself require a contract between the two manufacturers (see Section 5 of this guidance for further detail).
MDCG 2023-7 - Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR
MDCG 2023-7 - Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence - December 2023
health.ec.europa.eu
