Compliance & Product Regulatory ApproVals

EU Commission

Proposal for Extension period for MDR/IVDR

 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 with regard to the  transitional provisions for certain medical devices and in vitro diagnostic medical devices.

The new regulations create a transparent and sustainable regulatory framework which is recognised internationally to ensure quality, safety and performance of devices placed on the EU market.

 The MDR (Medical Device Regulation) has been applicable since 26 May 2021 and the IVDR (In Vitro Diagnostics Regulation) has been applicable since 26 May 2022 in Europe.

EU parliament adopts extension of its transition period in January 2022 as shown below. This applies to devices placed on the market before or during the transition period and still in the supply chain.

 26May 2025 for high risk in vitro diagnostics

26May 2027 for Low risk in vitro diagnostics

26May 2028 for devices manufactured and used in health institution.

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