Impact of the MDR Amendment on countries recognizing EU CE marking

On 6 January 2023, the European Commission proposed a Regulation to amend the transitional provisions of the Medical Devices Regulation (MDR – (EU) 2017/745) and the in-vitro Diagnostic Medical Devices Regulation (IVDR – (EU) 2017/746). On 16th February and March 7th respectively, the European Parliament and the Council of the European Union officially adopted the proposed amendment. The amendment was published in the Official Journal of the European Union on the 20th of March 2023, and immediately entered into force.

The overall goal of the proposed amendment is to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new regulatory framework and to allow enough time to address the capacity issue of notified bodies.

Key changes introduced by the Amendment include but are not limited to:

1. A staggered and conditional extension of the transition period as follows:
   1. Timing to comply with EU MDR requirements:
      1. Until 26 May 2026 for class III implantable custom-made devices
      2. Until 31 December 2027 for higher risk devices (class III devices and certain class IIb implantable devices).
      3. Until 31 December 2028 for medium and lower-risk devices (other class IIb devices, class IIa, class Im, Is and up classified devices).
   2. Extension of the validity of certificates issued by Notified Bodies under Directive’s 93/42/EEC and 90/385/EEC, which meet certain conditions:
      1. continued compliance with applicable Directives
      2. no significant changes in the design or intended purpose
      3. no unacceptable risk to health or safety
      4. manufacturers QMS in place in accordance with MDR by 26 May 2024
      5. formal application for MDR conformity assessment for the device or the device intended to substitute that device by 26 May 2024 & written agreement established between manufacturer and notified body by 26 September 2024.
2. Removal of ‘sell-off’ date: Consequently, devices placed on the market before the end of the transition period can be made further available on the market without a legal time restriction. The deletion of the sell off period is also applicable to the IVDR.

It is important to note that the amendment introduces an extension of the validity of the Directives certificates by law, i.e., the date on the certificate will not be changed, as re-issuance of the certificates with a new date would require significant capacity from Notified Bodies.

For this purpose, the European Commission has published an FAQ document on their website covering practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards to the transitional provisions for medical devices and IVDs that we attached to this communication. Multiple scenarios are being considered on EU level to address the impact of this extension for international markets:

1. A harmonised manufacturer self-declaration template confirming that the conditions for the extension are fulfilled, stating the end date of the transition period (see page 5 Part B Question 7)
2. Notified Bodies ‘confirmation letter’ stating the receipt of the manufacturer’s application for conformityassessment and the conclusion of a written agreement (see also page 5 Part B Question 7)
3. The Commission is also planning to update its fact sheets for competent authorities in non-EU/EEA countries, explaining the functioning of the extended transition period.

As the amendment comes as an urgent relief, ensuring continuity of supply of life saving and life enhancing devices, we recommend for the markets in our region which recognize the EU CE marking to consider a pragmatic solution and align with the EU proposal covered in the Q&A document, which would allow a continued supply of the Medical Technology to the patient in MEA region.

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