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Timelines for Transition of Certification from MDD to MDR

As of March 20, 2023, Regulation (EU) 2023/607 was published to smoothen the transition from MDD (and AIMDD) to MDR certification of devices on the market and to assure availability of medical devices on the European market. Manufacturers of devices certified according to Medical Device Directive (MDD), also known as "legacy devices" according to MDR Article 120, can now benefit from longer periods for the transition of MDD certification to MDR. In order to be able to benefit from this extension let's delve into the key highlights:

 

Extension of MDR validity of certificates:

All certificates not expired on March 20, 2023 have been extended by definition until December 31, 2027 (for class III and class IIb implantable legacy devices) and until December 31, 2028 (for other class IIb and class IIa, as well as class Im and Is legacy devices).

It has to be noted that an additional prerequisite for placing devices on the market has been introduced: additional to the valid MDD certificate the manufacturer must have applied for the individual device (or a successor device) for MDR certification by May 26, 2024.
The notified body can then issue a confirmation letter (as defined in the Q&A document by the European Commission) confirming formally the validity of the MDD certificate.

However, it's important to note that the extension is subject to certain conditions to benefiting from the new transition period. Manufacturers must:

  • by May 26, 2024 establish a quality management system (QMS) compliant with MDR;

  • by May 26, 2024 submit a formal application for conformity assessment under MDR;

  • by September 26, 2024 have a mutually signed written agreement with the Notified Body for conformity assessment under MDR.

Additionally, the extension of the transitional regime only applies to MDR legacy devices that:

  • continue to comply with Directive 93/42/EEC;

  • do not undergo significant changes in design or intended use;

  • do not pose unacceptable risks to the health and safety of patients and users.

The new regulation also introduces additional requirements for legacy devices with expired certificates. Also such devices may benefit from the extended transition period either if the manufacturer had concluded a contract with a Notified Body for conformity assessment under the MDR before the expiration of the MDD certificate or has obtained exemptions under Article 97 or 59 MDR.

This extension of the transition period addresses the demands of the medical device industry, which has long sought a more flexible certification deadline for MDD legacy devices. It is good news for medical device manufacturers. However, it is crucial to act promptly and meet the first deadline of May 26, 2024, to ensure compliance with the new rules.

In this context we may also remind on the revision of MDCG 2020-3 (Rev. 1) on the definition of significant changes. The document gives clarification on the conditions when a change can be considers as “non-significant” and thus be implemented under an existing MDD certificate. This is especially crucial to adopt devices in the next four to five years to maintain safety and availability in the transition period.

Additional transition periods for Custom made devices:

Implantable class III custom made devices need to have a quality management certification according to Annex IX, by May 26, 2026 in order to continue to place these devices on the market.

Removal of the "sell-off" period:

The new regulation eliminates the previously defined "sell-off" period stated in MDR, Article 120(4).

Additional transition periods for Annex XVI devices:

Also the timelines for implementation of MDR for products without an intended medical purpose (Annex XVI, MDR) have recently been extended. By Commission Implementing Regulation (EU) 2022/2346 the legal framework, i.e. the Common Specifications, for certification of Annex XVI devices was generally established. The original version was also amended to align the transition periods with definitions of Regulation (EU) 2023/607 – this was published on June 20 2023 as Commission Implementing Regulation (EU) 2023/1194. It was clarified that if the device was MDD certified timelines of Art. 120 MDR (see above) shall apply. In all other cases (device not MDD certified) also the timeline for transition of the devices to MDR certification are extended.

Prerequisites:

  • Device was lawfully marketed in the Union before 22 June 2023

  • in continuous accordance with applicable requirements and

  • not substantially changed.

Applicable Timelines for Annex-XVI-devices the manufacturer intends to perform or is performing a clinical investigation (CI):

  • 22 June 2024: confirmation by the National Competent Authority acc. to Art. 70 (1) or (3) MDR that the application for the CI is complete;

  • 23 December 2024: the sponsor must have started the CI;

  • 1 January 2028: written agreement for the conformity assessment has been signed with the Notified Body must be in place;

  • 31 December 2029: end of transition period.

Applicable Timelines for Annex-XVI-devices the manufacturer does not perform a clinical investigation:

  • 1 January 2027: written agreement for the conformity assessment has been signed with the Notified Body must be in place

  • 31 December 2028: end of transition period

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