Rene',
Just wanted to make a comment that while equivalence can be based on one device only from MEDDEV 2.7/1 Rev 4 Appendix A1, there is still footnote 14 that allows additional devices to be used. Similar to the FDA's paradigm of a single predicate device or primary predicate device, you can include as many "reference" devices in a 510(k) submission as you want to help support equivalence. The same holds here as well with CE Marking; can include as many equivalent devices to support safety and performance. What has been made clear is that equivalent devices need to address clinical, technical,
and biologic characteristics when examining equivalence. I reviewed many CERs in the past where just any device was included to address one characteristic or a laundry list of devices were included that had no evaluation performed at all - just a list - and of course knowing the intended use helped haha !
The key words with the MDR in Article 61 is that: 'shall be based on clinical data providing sufficient clinical evidence' which as can be expected can be a myriad of activities. While I agree that your list may be sufficient, if you read Article 61 and Annex XIV, the whole clinical evaluation process is a bit more involved. Meaning that clinical evaluation must first be planned, and then clinical evidence could be literature, investigations, current product history, new product information, post market clinical follow-up, general safety and performance requirements, equivalent devices, benefit-risk ratio (risk management), intended use, and life-cycle of device. There are many facets of "clinical evaluation" that need to be considered now especially as an integrated process with the QMS through validations, product changes, risk management, usability, etc. etc. etc.
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 23-Jan-2018 13:46
From: Rene' Hardee
Subject: Clinical Evaluation compliance routes with MDR
Hello colleagues!
The time has come to really start a deep dive into the MDR as it relates to Clinical Evaluations. For our Class I and IIb devices, I have authored many CERs to MEDDEV 2.7/1 REV 3 and a couple of CERs to the MEDDEV 2.7/1 REV 4 edition using the single device equivalence route.
As I read through the MDR, it appears there are three conformity paths for our products:
1) Claim equivalence to another device, per Article 61 part 3.
2) Justify that conformity using clinical data is not appropriate, per Article 61 part 10.
3) Conduct a Clinical Investigation, per Article 62.
Do you agree these are the defined routes? Am I missing any?
I need to complete a CER for a software device that is a combination of 3 Class I medical devices, and I want to get a head start on being compliant with the MDR. I don't see anywhere in the MDR that we are explicitly prohibited from claiming equivalence to more than one medical device. However, just like in a 510k, I may be better off claiming equivalence to a "primary" device and just use the other two devices as additional evidence. Thoughts or opinions?
Thanks!
-Rene'
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Rene' Hardee
Sr. Regulatory Affairs Specialist
Melbourne FL
United States
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