Gap Analysis between MEDDEV 2.7/1 rev.4 vs. rev.3 wanted

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eyalhend

Starting to get Involved
#3
Thanks Ronen
I'm familiar with the suggested reference.
Still, would appreciate if someone can share a more thorough gap-analysis.

Great thanks
 
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shimonv

Trusted Information Resource
#4
Hi,
This is from my personal notes. It's not a gap analysis per se, but rather highlighting the key cnanges compared to rev. 3.
A summary of what I found:

1. Clinical Evaluation throughout device lifecycle is a key aspect in this revision 4; when new information from post market surveillance (PMS) affects the clinical evaluation report, it is expected that post-market data is fed into the clinical evaluation in a timely manner.
2. “Equivalence” can only be based on a single device which means all of the three general criteria (clinical, Technical, biological) must be fulfilled by a single device.
3. Human factors / usability for the intended users is now specifically included in the list of things to be considered by evaluators in the clinical evaluation.
4. The only clinical data that are considered relevant are those obtained from a medical device that conforms to the requirements of the MDD/AIMD in Europe. This means that for “equivalent” medical devices that have a PMA approval or 510(k) clearance in the US, the manufacturer must justify any issues concerning differences in patient population or clinical practice between the jurisdictions.
5. Frequency at which the clinical evaluation report needs to be actively updated needs to be defined and justified by the manufacturer based on risk level, degree of innovation, level of confidence etc. For products that pose a significant risk to the user / patient this needs to be performed at least annually and in any other case with a frequency of 2 to 5 years. These requirements will most probably lead to a significant increase in resourcing in certain companies.
6. The requirements regarding the qualification of the evaluators of clinical data have increased. Evaluators should have knowledge of clinical investigation design and biostatistics, regulatory requirements and experience in medical writing. Furthermore, they must have a higher degree and 5 years of documented professional experience or 10 years of documented professional experience if a higher degree is not a prerequisite for a given task. There is an escape clause for cases where the manufacturer can document and justify deviations from the above.
7. Clinical studies must be sufficiently large to have a reasonable probability of seeing undesirable side-effects. This will probably leads to an increas in the number of first in men and pivotal studies but also with regard to the number of subjects required.
8. Manufacturers are expected to include the supporting non-clinical information (e.g. pre-clinical reports)
9. Definition “clinical evidence” was added in the guidance (based on GHTF SG5/N2R8:2007)
10. For the assessment of clinical evaluation reports, the notified bodies must have documented procedures in place and reviewers need to provide objecctive evidence regarding their qualification / expertise. In addition, they are now required to write a Clinical Evaluation Assessment Report (CEAR) in all cases (this can be part of the design dossier or technical file report).


Cheers,
Shimon
 
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