The equivalence requirements of MDR Article 61 Sections 4 and 5 have been interpreted conservatively thus far by notified bodies and industry. It's simple – for Class III and implantable devices, the manufacturer cannot leverage data from an equivalent device unless the equivalent device either belongs to that manufacturer or that manufacturer has a contract with the equivalent device's manufacturer allowing access to their data. If those requirements cannot be met, the MDR states that the manufacturer must undertake clinical investigations.
Manufactures and notified bodies have assumed that clauses 61(4) and 61(5) mean that:
Is this really what Article 61 says? If it is, we're all aware that many devices will be exiting the market.
In this discussion, we'd like to examine this section of the MDR more deeply and with an open mind. For example, nowhere in article 61 does it state that you cannot use data from equivalent devices which do not meet these criteria – nor, for the most part, does the subsequent guidance on equivalence, MDCG 2020-5. It just says that you must conduct a clinical investigation unless the data comes from one of the defined sources. What if the complete data package is comprised of a combination of sufficient data from an equivalent device that meets the Annex XIV clause 3 criteria, but not the additional requirements of Articles 61(4) and (5)) and a small clinical data set on the subject device ….would that be enough? In addition, Article 61(6) says nothing about the source of equivalence data for legacy or exempted devices, rather, it says that the requirement for clinical investigations do not apply to these devices. In this case, a literal interpretation of this clause would mean that legacy class III and implantable devices can also not only use data from equivalent devices which do not meet the Article 61(4) or (5) criteria, but there is no requirement for a pre-market clinical investigation either.
Finally, although Article 61(4) says “clinical investigations shall be performed”, it does not say when they shall be performed. The definition of clinical investigation in Article 2(45) includes any study undertaken on human subjects to assess safety or performance, regardless of whether than study takes place pre- or post-market. Could the requirement for a clinical investigation be met by a post market study?
Let's talk about this new perspective on the equivalence requirements of EU MDR Article 61, look for flaws in the argument, and hear from anyone in industry who has attempted it. Join the discussion with our panel of subject matter experts including former notified body leader, Amie Smirthwaite:
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