Module 18 2021

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2/9/2021

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. MDCG 2020-13

Literature Searches

Address all device sizes, variants, model and accessories?

Address the same clinical condition? ( Think back to your indication!)

The state of the art or alternative available treatment option?

The device under evaluation or to a device demonstrated to be equivalent?

A detailed analysis of search results is required - Quantification of risk/benefit where possible.

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

Clinical Evidence – MDCG 2020-6 Evidence Source 1 High Quality Clinical Investigations 2 Medium Quality Clinical Investigations 3 High Quality Registry Data 4 Justifiable Studies with some Methodological flaws / High Quality Surveys 5 Equivalence Data (Reliable/Quantifiable) 6 Evaluation for State of The Art/Similar Device Evidence (WET Article 52) 7 Complaints, Vigilance. 8 Proactive PMS data such as surveys 9 Case Reports/Studies 10 Compliance to Non- Clinical Specifications 11 Animal study data 12 Pre-clinical/Bench Testing/Compliance to Non-Clinical Standards

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