MEDDEV 2.7/1 rev 4: What you need to change in your clinical evaluation process?

Rob Packard

Ship & Print Your FDA eCopy

January 2017

2 min reading time

MEDDEV 2.7/1 rev 4 is completely re-written from rev 3. The fourth edition is 19 pages longer and it is now much harder to use the “literature only” route. The fourth revision includes stringent requirements for demonstrating equivalence between another device and your device. Therefore, many companies are now struggling to update their clinical evaluation reports to satisfy this new guidance document.

The third and fourth revisions of the guidance both have a 5-stage process for clinical evaluations, but in the third revision only articulated stages 1 through 3 as stages leading up to writing a clinical evaluation report. The figure in section 6.3 of revision 4 now identifies a planning Stage 0 and the writing of the clinical evaluation report is referred to as Stage 4. Therefore, there is a lot more detail describing the planning and report writing stages than there was in revision 3. In addition, Stage 2 (Appraisal of clinical data) has been expanded from a single page to eight pages.

There is also much more guidance and more examples provided in the appendices, while the 12-page clinical evaluation checklist that was provided in revision 3 has been replaced by one page of bulleted items for Notified Bodies to consider.

It is no longer sufficient to list several devices that are similar to your device and include those devices in your search of clinical literature. Now you may only select one device for equivalence. You must also provide a thorough analysis of equivalence with that device on the basis of clinical, technical and biological characteristics. This comparison includes providing drawings or pictures to compare the size, shape and elements of contact with the body.

The frequency of updating your clinical evaluations must be justified and documented. Devices with significant risks (e.g., implants) require at least annual updates to the clinical evaluation report. For devices with non-significant risks, 2-5 years is the range of possible frequency.
There are seven steps that need to be included in your quality plan for compliance with MEDDEV 2.7/1 rev 4:

1. update your external standards to replace MEDDEV 2.7/1 rev 3 with MEDDEV 2.7/1 rev 4
2. revise your procedure and associated templates for a literature review and clinical evaluation report to meet the requirements of MEDDEV 2.7/1 rev 4
3. document the qualifications of evaluators for clinical evaluations
4. document a plan/schedule for updating your clinical evaluation reports for each product family
5. train evaluators, regulatory personnel and any applicable internal auditors on the requirements of MEDDEV 2.7/1 rev 4 and updated procedures and forms
6. begin updating clinical evaluations according to your plan
7. perform an internal audit of your clinical evaluation process

If you are interested in learning more about this revised guidance document, the full-length article can be found on my blog page: http://www.medicaldeviceacademy.com/blog/.

I am also teaching a live webinar on Friday, January 27 @ Noon EST specific to MEDDEV 2.7/1 rev 4: http://www.medicaldeviceacademy.com/clinical-evaluation-procedure/.

source: https://www.linkedin.com/groups/2070960/2070960-6227351894122074113

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Posted by Rob Packard

Asked on January 18, 2017 12:00 am

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	Private answer Robert van Boxtel And realize that most NB's expect you to already be in compliance. They asked the EC on the transition period and the answer was: "there is none". A new proposition on this is brewing and NB's understand the challenges for manufacturers on this. But they also maintain their position: compliance. now. At least as long as the competent authorities maintain that position. Which might be different in each member state... So talk to you NB on their expectations. Not having a transition plan by now will result in a non-conformity with some NB's (if not most). Yes, you get NÇ's on not complying to an EC guidance. Even though the first page of that MEDDEV has a very interesting note. And in 2. Scope "This guide is not legally binding;" Food for thought... Marked as spam Report spam
	Private answer Robert van Boxtel And realize, some if not all NBs are considering this guidance to be law, without a transitional period. meaning you have to be in compliance. now. Since publication. Because that's what has been stated by the EC in response to clarification of a transitional period by the NBs. Marked as spam Report spam
	Private answer Thank you for this great summary of new Meddev.. Marked as spam Report spam
	Private answer thank you very much sir Marked as spam Report spam
	Private answer Daniel John Adding to Mr. Boxtel's comment, US FDA also has guidance documents which state that, quote, "This document is intended to provide guidance. It represents the Agency’s current thinking on the above. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both". Hence US FDA can accept an alternative approach to that of a FDA guidance. Section 2.Scope, of MEDDEV 2.7/1 rev. 4, also mentions alternative approach but it is followed by, quote, "it is anticipated that this guide will be followed within the Member States, thereby supporting uniform application of relevant provisions of EU Directives and common practices". Hence all NB's would logically want manufacturers to follow this guidance, as it is, and all deviations adequately justified/accepted by NB. Marked as spam Report spam
	Private answer Ruud Lans Search for White papers free download e.g Bsi, Qserve, emergency, Marked as spam Report spam

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