Module 16 2022

02/09/2022

Vigilance under the MDR

Manufacturers must report to the relevant authority: ● Serious incidents involving device on the market in the EU, unless expected side effect documented in product information ● field safety corrective actions in respect of device on the market in the EU – including field safety corrective actions of same device in non-EU countries unless reason limited to device in non EU country (Art. 87) Timelines – immediately and in any event no later than ● 10 days after establishing causal link for death or serious deterioration in health ● 15 days after establishing causal link for other incidents ● 2 days for serious public health threats

Trend reporting ● Non-serious incidents that affect benefit/risk assessment

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Transitional Arrangements

Article 120 of the MDR contains transitional provisions ● Devices CE marked under MDD with NB certificates can be placed on market until the expiry of certificate or until 26 May 2024 (Article 120(3) of the MDR) ● Can continue to be made available until 27 May 2025 (Article 120(4))

Article 122 of the MDR clarifies ● MDD is repealed, subject to Articles 120(3) and (4),

● MDR device vigilance rules apply, with the exception of the requirements to report via For EUDAMED2, which will apply 6 months after the Commission gives notice that the EUDAMED2 vigilance module is operational ● Existing requirement to report to national authorities remain

IVDR contains similar provisions

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