Essentials of European Medical Device Regulatory Affairs

Vigilance What must be reported? MDR Article 87 Manufacturers …… shall report, to the relevant competent authorities……. the following:

(a) any serious incident involving devices made available on the Union market, except expected side-effects:

- clearly documented in the product information and - quantified in the technical documentation and - subject to trend reporting

(b) any field safety corrective action in respect of devices made available on the Union market, including:

- FSCAs outside the EU if relevant to the CE marked device

Electronic reporting - EUDAMED database

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Vigilance

Incident (article 2 (64))

Any malfunction or deterioration in the characteristics or performance of a device, made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect

Use Error (MEDDEV 2 12-1 rev. 8 Vigilance)

Act or omission of an act that has a different result to that intended by the MANUFACTURER or expected by the OPERATOR

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