The Rev 4 is emphasized more
on the scientific outlook of the clinical evaluation, the competence and independence
of the clinical evaluators, and the need to make this a living document that
must be updated regularly or whenever there is a safety or clinical performance
issue. Rationale to the clarifications and new requirements in the clinical
evaluation process are as follows:

Rationale to the clarifications and new requirements:

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1.       
Clarification on frequency of updating
CER report: Section 6.2.3 states that the CER needs to be updated at
least annually if the device carries significant risks or is not yet well
established, and every
2 to 5 years for lower risk and well established devices with a justification. CER needs to be updated when new
information or relevant changes viz., changes in clinical
sciences, materials sciences or other sciences related to the device under
evaluation; the data available from clinical investigations, PMCF studies,
registries or other systematic studies; the total number of devices used so far
in the market, risks and uncertainties or unanswered questions, in the medium
or longterm, that would influence the frequency of updates; design changes or
changes to manufacturing procedures; manufacturer receiving new information
from PMS that has the potential to change the current evaluation.

 

2.     
Inclusion of additional two new stages: Section
6.3 explains additional 2
stages which are: stage 0 – scoping, plan and stage 4 – finalizing the CER. It emphasizes
on :
1. being compliant with the essential requirements (ER1, ER3, ER6) on
performance and safety of the device along with risk benefit profiles.
2. considering all the contents of information materials
supplied by the manufacturer (including the label, IFU of the device, available
promotional materials, including accompanying documents possibly foreseen by
the manufacturer).

3. residual risks/uncertainties/unanswered
questions which can be either acceptable for CE marking or required to be
addressed during PMS.

 

3.      
New
requirement: Expertise and
experience of  CER authors and evaluators: Section 6.4 introduces specific requirements for the expertise and
experience of CER authors and evaluators, including a relevant higher education
degree qualification and professional experience. Only very few of the past authors qualify as future authors
due to new and stricter qualification requirements. So the single author will
have a hard time to comply with the requirements alone. It can be expected that
we will witness a shift from one author to a team of authors, each with
specific skills to complement the overall requirements. 

 

4.     
Concerning
current knowledge/the state of the art: Section 8.2 states that copies of the full text
papers and documents to be obtained for the appraisal stage. This section is
more detailed in establishing and documenting the state of the art. This also includes
establishing the safety and performance of the device, it’s claimed equivalent,
and any benchmark or other similar devices, as well as the risks and benefits
of other available treatment options.

 

5.     
Documentation of appraisal plan: Section
9.2 points out that an
appraisal plan must be documented in the CER. This is done to ensure systematic
and unbiased appraisal of the data.

 

 

6.     
Scientific validity of data: Section
9.3.1 and Appendix
7 and 7.2 emphasizes on the demonstration of the
scientific validity of data, including statistical considerations, adequacy of
disclosure of data, study design for pre and post market investigations. This
is done to address factors which could affect the scientific validity of
different types of datasets including literature search
and retrieval methods, data appraisal and weighting, and the analysis of data
and demonstration of conformity.

 

7.     
Essential factors while selecting pivotal
data: Section 9.3.2 emphasizes on the factors essential while selecting
pivotal data and other data the different aspects to be taken into
consideration when determining relevance to the subject device.

 

 

8.     
CV & declaration of interest: Section
11 mentions that the clinical evaluators should provide their
CV and their declaration of interests to the manufacturer. The clinical
evaluation report should be dated and version controlled to enhance the effectiveness
of the CER.

 

9.     
Clinical
evaluation requirement: Appendix 2 explains the key
considerations relating to device risk and procedure to determine if they have
sufficient clinical evidence by the manufacturers.

 

10.  
Post
Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF): Appendix
12 highlights the requirement for Notified Bodies to ensure
that PMCF is planned and appropriately justified.

 

11.    
Equivalent
devices data: Appendix A12.2.3
mentions a new requirement which will require a manufacturer to have a contract
in place allowing access to data for competitor devices with which equivalence
is claimed.

 

Upshot

Failure to properly execute
any of the key requirements listed above is likely to invalidate CER. Implementation
period has not been decided for Rev 4. However,
it is expected that the all the CER reports are prepared and updated (older) in
accordance with the REV 4. Broader expectations are being laid on the NB and
the expertise requirements of the evaluators. Therefore, MEDDEV 2.7/1 is helpful for
manufacturers and notified bodies, if seen from the perspective that it
provides a smooth transition from nice to have to must have. The focus of clinical evaluation at various stages of product
lifecycle is precise and updating it frequently is mandatory, alarming the
importance of medical device clinical investigations.