星期五, 6月 21News That Matters
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“The extension of the transitional period and the removal of the “date of sell” provision in MDR.”

The goal of MDR/IVDR – The amendment to regulations (EU) 2023/607 for the revision of MDR and IVDR aims to ensure a high level of public health protection, including patient safety and the avoidance of medical device shortfalls necessary for the smooth running of medical services, without compromising the current quality or safety requirements. To this end, manufacturers and notified bodies have sufficient time to conduct conformity assessments of devices covered by certificates or declarations of conformity issued under directive 90/385/EEC or directive 93/42/EEC in accordance with the MDR. In addition, the “date of sale” is removed from the MDR and IVDR to prevent unnecessary disposal of safe equipment.

In Article 120(4) of the MDR and Article 110(4) of the IVDR, the deadline for further placing on the market devices placed on the market under previous directives has been removed. This means that medical devices placed on the market before May 26, 2021, under the MDD/AIMDD or during the transitional period specified in Article 120 of the MDR (until December 31, 2027, or December 31, 2028, if applicable), can continue to be made available or put into service on the market without any time limits, without affecting the possible shelf life or expiry date of the device.

The same applies to in vitro diagnostic medical devices placed on the market before May 26, 2022, under the IVDD, or during the transitional period specified in Article 110 of the IVDR (until May 26, 2025, May 26, 2026, or May 26, 2027, depending on the case). These IVDs can continue to be made available or put into service on the market without any time limits, without affecting the possible shelf life or expiry date of the device.

Article 120(4) of the MDR and Article 110(4) of the IVDR have removed the deadline for further placing on the market of devices previously placed on the market under previous directives. This means that medical devices placed on the market before May 26, 2021, under the MDD/AIMDD or during the transitional period specified in Article 120 of the MDR (until December 31, 2027, or December 31, 2028, if applicable), can continue to be supplied or made available on the market without any time limits, without affecting the possible shelf life or expiration date of the device.

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