Module 16 2024

23/10/2024

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

Subject to certain conditions, Article 120 of the MDR contains transitional provisions until ● 31 December 2027, for all class III devices, and for certain class IIb implantable devices; ● 31 December 2028, for other class IIb devices, class IIa devices, and for class I sterile or measuring devices

Article 122 of the MDR clarifies ● MDD is repealed, subject to Articles 120(3) and (4),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 EUDAMED2, which will apply 6 months after the Commission gives notice that the EUDAMED2 vigilance module is operational – expected Q1 2026 ● Existing requirement to report to national authorities remain

IVDR contains similar provisions

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