Section D — Clinical literature review

Source: MDCG-2020-01.pdf pages 16-18 (document: MDCG 2020-13)

With respect to the search criteria of the literature review, does it:

• Address all device sizes, variants, model and accessories?
• Address the same clinical condition?

Further information regarding literature search methods is available in MEDDEV 2.7/1 revision 4, section A5.

Searches for the device in question, equivalent devices and other devices (for example to support a description of the state of the art) should be described separately.

With respect to the selection criteria of the literature review, does it relate to both below:

• The device under evaluation or to a device demonstrated to be equivalent?
• The state of the art or alternative available treatment option?

The clinical evaluation should clearly describe the selection criteria with respect to the regulatory purpose to which it will apply. The CER should clearly differentiate between the two types of data referenced above. If the data does not relate to either of the above, provide a rationale with respect to its inclusion.

Literature search protocol¹

Provide a brief summary of the literature search strategy applied, commenting on:

• The adequacy of search terms: for example, it should be sufficiently broad to establish benchmarks, determine the general state of the art, determine potential risk, adverse events, undesirable side-effects, etc.

  Note that a search which is restricted to the manufacturer's own product or the name of their chosen equivalent could miss important information and therefore is not acceptable.

• Databases used (to minimize bias multiple databases should be used).

• Acceptability of inclusion and exclusion criteria.

• Both favourable and unfavourable data included.

• Strategies for avoiding duplication of data (for example, across different publications or between manufacturer and published data).

• Literature search and review protocol (i.e. how did the manufacturer test this protocol to ensure comprehensive identification of relevant data / demonstrate that all relevant data has been retrieved?).

• Any deviations from the manufacturer's literature search protocol.

• Overall conclusions regarding the adequacy of search methods, likelihood of having retrieved all relevant data, and methods used to avoid bias.

Comment if systematic search and review methods such as the following have been used:

• PICO (patient characteristics, type of intervention, control, and outcome queries).
• Cochrane Handbook for Systematic Reviews of Interventions.
• PRISMA (The Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement.
• MOOSE Proposal (Meta-analysis Of Observational Studies in Epidemiology).
• Other (specify or describe).

Literature search documentation:

• Literature search protocol provided
• Literature search reports provided
• Full list of retrieved articles provided
• Full list of excluded articles provided, with reasons for exclusion
• Full text copies of relevant documents available

Comments:

Provide rationale if any of the above has not been provided.

Nota bene:

• A literature search and other retrieval of data should be carried out based on a search protocol. The search protocol should document the planning of the search before execution.
• Once the searches have been executed, the adequacy of the searches should be verified and a literature search report should be compiled to present details of the execution, any deviations from the literature search protocol, and the results of the search.
• It is important that the literature search is documented to such degree that the methods can be appraised critically, the results can be verified, and the search reproduced if necessary.
• Abstracts lack sufficient detail to allow issues to be evaluated thoroughly and independently, but may be sufficient to allow a first evaluation of the relevance of a paper. Copies of the full text papers and documents should be obtained for the appraisal stage.
• The literature search protocol(s), the literature search report(s), and full text copies of relevant documents using URL links, become part of the clinical evidence and, in turn, the technical documentation for the medical device.

Non-compliances identified and resolved for this section may be briefly described in this box

Literature search protocol and outputs are:

• Compliant with the applicable requirements of the MDR:

Include any relevant comments

• Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below:

Add a clear description of any remaining minor non-compliance together with required follow-up actions to close them and timelines for their completion to be followed by the manufacturer.

Data appraisal:

Provide a brief summary of the manufacturer's data appraisal methods (i.e. how they determine whether the data from a given study or other source of data is of sufficient quality and relevance to be included in the clinical evaluation. This includes evaluation of criteria including study design, sources of bias, peer review, relevance to subject device, etc. Retrieved studies and data sets should be weighted on the basis of scientific quality and relevance to the scope and objectives of the clinical evaluation for the subject devices).

Justify the acceptability of the appraisal in terms of:

• Methodological quality and scientific validity of articles retrieved and evaluated appropriately.
• Relevance of the information to the clinical evaluation determined and documented.
• Contribution of each data set to the clinical evaluation weighted according to systematic criteria.

Footnotes

1. For general guidance on a literature search, see MEDDEV 2.7/1 revision 4, A5. Literature search and literature review protocol, key elements. ↩