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MDCG publishes guidance on MDR Article 120 transitional provisions

  • Posted by: inetika
  • Category: GLOBAL NEWS

The Medical Device Coordination Group (MDCG) of the European Commission has released a guidance document covering the ransitional provisions in Artilce 120 of the Medical Devices regulation (MDR, 2017/745) to clarify how manufacturers may take advantage of Notified Body certificates issued under the Medical Devices Directive (MDD, 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC)  while they remain within their periods of validity.

MDR Article 120 states that certificates issued in accordance with these previous directives will remain valid until their expiry dates or 27 May 2024, whichever is the sooner. The guidance notes that Article 120(3) of MDR establishes that the notified body that issued the certificate continues to be responsible for the appropriate device surveillance activities beyond the date of application of the MDR (26 May 2020). The guidance reiterates the FAQ answer from the MDR transitional provision document published by the CAMD Transition Sub Group, stating that “the contract between the manufacturer and the notified body who issued the certificate under the relevant Directive shall include provisions allowing the appropriate performance of such surveillance activities”.

The guidance notes that whether a notified body has applied or not to be designated under MDR does not matter under these circumstances.

The document also notes that any notified body notification published in NANDO in accordance with the directives will be voided beginning 26 May 2020, when MDR takes effect, adding “Therefore, NANDO will only be used in relation to the Directives for information purposes after 25 May 2020. NANDO will therefore list those notified bodies that have been designated under the Directives with a clear message that they are not able to issue new certificates but only allowed to carry out surveillance activities for valid certificates in the transitional period, as established in Article 120 of the MDR”.