The MDCG has released a guidance document regarding exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR. This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices to be placed on the European market. It also provides examples and considerations relevant to the demonstration of “sufficient levels of access to the data” per Annex XIV Section 3.
To offer some background to this guidance document, Article 61(4) states that clinical investigations shall be performed for implantable and class III devices. That being said, indents 1-3 of Article 61(4), Articles 61(5) and 61(6) outline exemption cases in which clinical investigations can be exempted for such devices. The exemptions are explained in detail in this document, furthermore, the cases for exemption are tabulated for ease of reference.
The end of the document sees the addition of 2 Appendixes which are very helpful in explaining the concepts discussed in this document. Appendix I shows a flowchart to help better explain the scenarios in which clinical investigations can be exempted for a Class III implantable device. Appendix II shows a Hierarchy of levels of access to the data regarding the clinical, technical and biological characteristics to be considered for the demonstration of equivalence.
The guidance document can be accessed using the following link