| Date | Guidance No | About the guidance |
|---|---|---|
| 30 Jun 2023 | Add 1 – MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate Addendum 1 – June 202 | The position paper MDCG 2022-18 was published in December 2022 to provide a uniform approach to the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) in situations where a certificate issued under Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR. The use of Article 97 MDR in those situations was meant to be a temporary solution. The goal of the position paper MDCG 2022-18 was to contribute to avoiding disruption of supply of devices on the EU market needed for health systems and patients. With the entry into force of Regulation (EU) 2023/607 on 20 March 2023 , the MDR transitional period and the validity of MDD/AIMDD certificates have been extended, provided that the conditions in the amended Article 120 MDR are met. Regulation (EU) 2023/607 has averted the imminent risk of shortages of critical legacy devices related to the expiry of MDD/AIMDD certificates. The MDCG therefore considers that the application of Article 97 MDR in accordance with MDCG 2022-18 to situations where a MDD/AIMDD certificate has expired prior to the issuance of a MDR certificate has achieved its objective and is not relevant any more. The MDCG recommends that national CAs limit the application of Article 97 MDR as set out in MDCG 2022-18 to very exceptional situations, e.g. where the national competent authority (CA) has received information justifying the application of Article 97 MDR prior to 20 March 2023. Where, after 20 March 2023, a competent authority has required or requires a manufacturer, in accordance with Article 97 MDR, to carry out the applicable conformity assessment procedure, the condition set out in Article 120(2), second subparagraph, point (b), of the MDR is not met. Therefore, the expired certificate will not be considered valid and the extended transitional period set out in Article 120(3a) MDR does not apply. |
| 12 May 2023 | UPDATE – MDCG 2020-3 Rev.1 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR – May 2023 | This guidance document: • is intended to provide clarification on the concept of ‘significant changes in the design and intended purpose’ under Article 120(3c), point (b) MDR. It concerns manufacturers of legacy devices. • does not elaborate on the process for manufacturers’ submission and notified bodies’ assessment of changes to the approved design10 or substantial changes to the approved quality system or the product-range covered. MDCG 2020-3 revision 1 changes – Chabnges throughout the document to align it with Regulation (EU) 2023/607 and guidance MDCG 2022-2. |
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medicines-medical devices-regulatory affairs