Hi Anon,
for Legacy Devices you do not have to fulfill the MDR GSPRs becaise they still only comply with MDD Annex I. In consequence MDR Annex I, 23.1(f) is not applicable.
That said: As far as I understand it, Article 10 of Regulation 2021/2226 repeals the previous Regulation 207/2021 but allows its application to Legacy Devices until May 2024 (they did not adapt this to the updated transition periods).
Best regards, Christoph
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Christoph Kiesselbach
Schrack & Partner
Reutlingen
Germany
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Original Message:
Sent: 31-Jan-2024 01:08
From: Anonymous Member
Subject: GSPR 23.1(f) IFU in webpage and Regulation 207/2012 or Regulation 2021/2226
This message was posted by a user wishing to remain anonymous
Dears,
My question is regarding GSPR 23.1(f) IFU in website:
Implementing Regulation 2021/2226 has replaced the previous EU regulation 207/2021, which was previously also valid under the MDR.
Does the Regulation 207/2021 remain valid for devices placed on the market or put into service during the transitional period according to Article 120(3) of the MDR (Article 122)? Or as the regulation 207/2021 has been repealed by Implementing Regulation 2021/2226 (14Dec2021), even for legacy devices we must align with Regulation 2021/2226 to fulfill GSPR 23.1(f)? cannot claim only alignment with Regulation 207/2021 for legacy devices?
Thx all for your comments and responses!!