Seminars and Events
2023.03.15 Council Regulation (EU)2017/745 MDR Amendment 2023/607 and FAQ on extension of CE certificate for MDD
A written MDR review contract with a notified body must be signed before the specified time (the old certificate is valid by September 26, 2024 at the latest) to apply the extended transition period. 2023/607 and FAQ on CE certificate extension for MDD
The main contents of the new transition period are refined
A. New transition period
1. High risk equipment transition period extended to 31 December 2027 (for all Class III devices and Class IIb implantable devices, excluding sutures, sutures, dental fillings, braces, crowns, screws, wedges, dental or bone plates, wires, pins, clips and connectors;)
2. The transition period for low - and medium-risk equipment is extended to 31 December 2028 (for Class IIb equipment, Class IIa equipment and Class I equipment placed on the market in a sterile state or with measurement functions other than those referred to in point (1) of this paragraph).
3. The transition period of Class III implantable custom equipment is extended to May 26, 2026;
(4) Allow medical devices placed on the market in accordance with the current legal framework and beyond the deadline for sale to remain on the market.
B. Conditions applicable to the extension of the transition period (subject to simultaneous satisfaction)
(1) Devices must continue to comply with Directive 90/385/EEC or Directive 93/42/EEC.
2. No significant changes have been made in the design and intended use of the device.
3. The device does not pose an unacceptable risk to the health or safety of the patient, user, or others, or to other aspects of the protection of public health.
4. The Manufacturer has established a Quality management System (QMS) in accordance with Article 10(9) of the MDR by May 26, 2024 at the latest.
(5) The manufacturer or its authorised representative has submitted a formal application for assessment of conformity to the notified Body under Section 4.3 of Annex VII to the MDR for "legacy equipment" or replacement equipment covered by a Directive certificate or Declaration of conformity before 26 May 2024, and has, before 26 September 2024, The notified body and the manufacturer enter into a written agreement pursuant to Section 4.3 of Annex VII to the MDR.
6. A certificate that expires before the entry into force of Amendment Regulation 2023/607 (i.e. 20 March 2023) shall be considered valid only if
Prior to the expiration date of the certificate, the manufacturer and the designated authority have signed a written agreement to conduct conformity assessment for the equipment covered by the expired certificate or for the equipment intended to replace the equipment
Or the competent national authority has granted a derogation pursuant to Article 59 (1) of the MDR, or pursuant to Article 97 (1) of the MDR requires the manufacturer to carry out the applicable conformity assessment procedure within a specified period of time (see Article 120 (2), subparagraph 2 of the MDR).
Note: 59 (1) refers to national exemptions for urgently needed public health needs, such as for COVID-19 testing agents during a pandemic. 97 (1) is an exemption for an unkonform, such as a medical device that is urgently needed. Both articles are exemptions in exceptional circumstances, which the competent authorities would not normally invoke.
7. Will a State derogation granted after 20 March 2023 under Section 59 of the MDR or the application of Section 97 of the MDR trigger an extension of the transition period?
No. If, after 20 March 2023, the competent authority grants a derogation under Article 59 of the MDR or requires the manufacturer to carry out the applicable conformity assessment procedures under Article 97 of the MDR, the conditions set out in point (b) of Article 120 (2) of the MDR are not met. An expired certificate will therefore not be considered valid and the extended transition period provided for in Section 120 (3a) of the MDR will not apply.
Therefore, the manufacturer must sign the MDR CE certificate audit contract with the notified body before the expiration date of the MDD CE certificate.
The key information interpretation of the extension of the new transition period
A. Applicable equipment
The bill targets Legacy devices and does not apply to medical devices that have not received an MDD or AIMDD certificate.
Legacy devices do not allow significant changes in their product design or intended use.
Products whose intended use has changed are not subject to the amendment extending this transition period.
B. 2 time points to be met for the extension of the transition period
In order to apply the transition period extension, manufacturers will need to enter into a written audit contract with the notified body before the expiry date of the old regulatory certificate or at the latest September 26, 2024.
Among them, two time points should be noted: The bill specifies that the manufacturer shall apply to the notified body by May 26, 2024 at the latest, and the two sides shall sign a written audit contract by September 26, 2024 at the latest. At the same time, the manufacturer should sign a written audit contract with the notified body during the validity period of the CE certificate of MDD.
In addition, it is not clear on the amendment bill whether to sign with the original certificate notified body, nor is it clear whether to limit the signing of one notified body, but it should be noted that it is not a letter of acceptance, but a written review contract.
C. By May 26, 2024, all legacy device quality system construction must comply with EN ISO 13485:2016 of the MDR.
Under the MDR regulations, many new quality system requirements are added, such as: clinical evaluation procedures, PMCF procedures, UDI procedures, etc. It is expected that in the future annual audit, the requirements of auditors for the quality system will gradually be in line with MDR Article 10.
All in all, the most important issue is: a written MDR review contract with a notified body, and must be signed before the specified time (signed during the validity of the CE certificate of the MDD) in order to apply the extended transition period.
Manufacturers whose certificates are about to expire, please complete the MDR application with the notified body as soon as possible until the contract is approved.
For more details, please refer to the following links:
2) Rev. 1 - Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607