Informational The future of MEDDEV 2.7/1

Ronen E

Problem Solver
Staff member
Moderator
#1
The following is quoted from a blog post on BSI's website:
The current European clinical evaluation guidance document, MEDDEV 2.7/1 Rev. 4, was developed to assist manufacturers in complying with Directive 93/42/EEC and Directive 90/385/EEC. It is not known, however, whether it will be revised in future to be fully consistent with the Medical Device Regulation (MDR; Regulation (EU) 2017/745), or whether the gaps between MEDDEV 2.7/1 Rev. 4 and the MDR will be filled by a series of additional guidance documents addressing specific aspects of the MDR clinical evaluation requirements.
Author: Maria E. Donawa, M.D., is President of Donawa Lifescience Consulting, Rome, Italy

I don't know whether "it is unknown" in absolute terms or just unknown to the author... :tg:
Some posts in Elsmar suggested that Rev. 5 is on its way.
 
Elsmar Forum Sponsor

dgrainger

Trusted Information Resource
#2
Have a look at the CAMD work priorities/roadmap: MDR/IVDR Implementation Taskforce - CAMD
Gap analysis is High priority but v5 is more of a maybe:

Guidance on requirements for vigilance reporting
• Identify gaps between the current MEDDEV and the MDR and IVDR (issue as Interim guidance via CAMD website with a view to updating a MEDDEV in due course)
• Details on how vigilance should be reviewed in clinical evaluation for MD and performance evaluation for IVD as well as the required detail of the investigations undertaken
• Focus on new MIR form, what vigilance looks like for member states, flag areas that are law rather than guidance and where MEDDEV needs to be updated to reflect the new Regulations
 

Sullen-gent

Starting to get Involved
#3
I was talking to someone who was of the commission working groups on guidance and they said the MEDDEV rev. 5 update was not forthcoming due to the sheer number of guidance documents needed for MDR.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I was talking to someone who was of the commission working groups on guidance and they said the MEDDEV rev. 5 update was not forthcoming due to the sheer number of guidance documents needed for MDR.
Thanks for sharing.
If this is true, I wonder what's going to guide NB practice regarding CER once they start auditing and certifying to the MDR. There seems to be a consensus that Rev. 4 comes short. As far as I understand the new IMDRF guidance represents some relaxation relative to Rev. 4 (disclosure: I haven't studied it yet).
 

Sullen-gent

Starting to get Involved
#5
I don't know how it will be handled regarding transfer to MDR, I know that BSi have pulled their CER training course with a view to re-releasing in Q3 this year. So that indicates to me, along with the above statement, that they have spotted the difficulty of imperfect overlap of rev.4 and MDR.

I don't really know how far the NBs have taken Rev.4 into current practice. I have heard of some organisations that haven't touched their CERs, but no findings in an audit. Also one of the TUVs said they weren't going to review rev. 4 until the MDR was implemented.
 
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