Healthcare, Industry News, Medical Devices, Regulatory Affairs

Second Corrigendum by EU MDR grants grace period for some self-certified Class I medical devices

The European Parliament adopted the second corrigendum of the Medical Devices Regulation (EU) 2017/745 (MDR)pg 44 of 145 for English, with significant compliance deadline implications for some currently self-certified devices.

This change suggests that devices (not custom made devices) that are self-certified Class I under the current Medical Devices Directive 93/42/EEC (MDD) but that will be up-classified under the MDR will not have to be certified to the newRegulation from the Date of Application (May 26th, 2020). Instead, qualifying devices may rely on the Declaration of Conformity drawn up under the MDD until May 25th 2024. This will impact many self-certified devices:

  • Class I reusable surgical devices;
  • Software, most of which would be up-classified to Class IIa or higher;
  • Many self-certified substance-based devices, of which some would be up-classified as far as Class III;
  • And many others.

Although most MDR requirements will apply, this delay in certification is not a delay in application of the MDR.

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