To avoid a real and imminent risk of shortages of devices on the EU market, the European Commission recently adopted Regulation (EU) 2023/607, extending the transitional provisions in Regulation (EU) 2017/745 (the “MDR”) and removing the sell-off period in the MDR and Regulation (EU) 2017/746 (the “IVDR”). The Commission has published a Q&A on the practical aspects of the latest changes (the “Q&A”). Below we set out the top 10 questions to think about when assessing how the changes to the MDR and IVDR may impact you and your medical devices.
As explained in our prior post, the Commission’s changes aim to address concerns regarding Notified Body capacity and the significant number of medical devices yet to transition to compliance with the MDR.
- What are the key changes?
The Commission has extended the transition period granted by the MDR for certain devices CE marked under the prior Medical Devices Directive 93/42/EEC (the “MDD”) and Active Implantable Medical Devices Directive 90/385/EEC (“AIMDD”). It does not change the existing transition periods in the IVDR. However, it removes the “sell-off” period from both the MDR and IVDR, meaning that legacy devices and IVDs already placed on the market can continue to be made available or put into service without being withdrawn.
In essence, the changes extend the period companies have to obtain MDR-compliant certificates and also provides more time for Notified Bodies to clear the backlog in their conformity assessments. However, given that the transition period does not apply to new medical devices the lack of Notified Body capacity may still lead to delays in bringing new products to market.
- Is my device covered by the transition periods?
The revised transition periods apply to legacy devices that meet certain criteria. However, they do not apply to (i) Class I devices that are not up-classified under the MDR, (ii) new devices nor (iii) devices intended to substitute an MDD device where the manufacturer has made significant changes with regard to the design or intended purpose of the MDD device.
- My device is a legacy device in Class IIa / Class IIb / Class III under the MDD. What are the new transition periods?
- Devices with Notified Body certificates valid on 20 March 2023
If a device has a Notified Body certificate of conformity that was granted on or after 25 May 2017, and which was still valid (and not withdrawn) on 20 March 2023, provided the manufacturer satisfies the requirements set out in question 5 below, the certificate shall remain valid after its expiry date until:
(a) “31 December 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
(b) 31 December 2028, for class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.” (emphasis added)
- Devices with Notified Body certificates that expired before 20 March 2023
If a device has a Notified Body certificate that was granted on or after 25 May 2017, which was valid on 26 May 2021 but expired before 20 March 2023, it can also benefit from the extended transition periods above but only if:
(a) before the date of expiry of the certificate, the manufacturer signed an agreement with a Notified Body in accordance with section 4.3 of Annex VII MDR covering the device with the expired certificate or the device intended to substitute it; or
(b) the Competent Authority of a Member State has granted a derogation under Article 59 MDR or has required the manufacturer, in accordance with Article 97(1) MDR, to carry out the applicable conformity assessment procedure within a specified period of time.
In addition, the manufacturer must satisfy the requirements in question 5 below.
- My device is Class I under the MDD/AIMDD but has been up-classified under the MDR. Do I have additional time to comply with the MDR?
Devices that are self-assessed under MDD/AIMDD but require a Notified Body certificate under the MDR (“up-classified devices”) (including software medical devices) can also benefit from the transition periods provided the manufacturer drew up a declaration of conformity for the relevant device before 26 May 2021. In such cases, the manufacturer can continue to place the device on the market until 31 December 2028, provided it satisfies the requirements set out in question 5 below.
- What conditions do I have to comply with to benefit from the transition period?
Eligible legacy devices will only benefit from the transition period if they comply with all the conditions set out in new Article 120(3c) MDR. This requires:
(a) the devices must continue to comply with MDD, as applicable;
(b) there are no significant changes to design or intended purpose;
(c) the devices do not present an unacceptable risk to health and safety of patients, users or other persons, or to protection of public health;
(d) by 26 May 2024 the manufacturer must have a quality management system (“QMS”) in place; and
(e) by 26 May 2024 the manufacturer must have submitted an application and entered into a written agreement with a Notified Body.
- What are the new rules that apply to Class III custom-made implantable devices?
Under the MDR, the conformity assessment of Class III custom-made implantable devices requires the involvement of a Notified Body. In light of this, the Commission has proposed an extension to the transition period for such devices. Class III custom-made implantable devices can be placed on the market/put into service until 26 May 2026 so long as:
- by 26 May 2024 the relevant manufacturer lodges a formal application with a Notified Body; and
- by 26 September 2024 the manufacturer and Notified Body sign a written agreement.
- How do I evidence my device benefits from the extended transition period?
If you meet the relevant conditions, the extension of the transition period will be applied automatically by law. During the transition period, Notified Bodies cannot
issue new MDD/AIMDD certificates. However, they can provide written confirmation correcting or complementing information on an existing certificate. As such, you can ask your Notified Body to update existing certificates to include the new expiry date.
To demonstrate validity of the MDD/AIMDD certificate to third parties, you could also consider:
- Providing a self-declaration confirming that the conditions for the extension are fulfilled and stating the end date of the transition period. The self-declaration should clearly identify the devices covered by the extension and certificates concerned.
- Obtaining a ‘confirmation letter’ from your Notified Body confirming receipt of the application for conformity assessment and the conclusion of a written agreement.
- What does removal of the “sell-off” period mean?
There is no longer a “sell-off” period in either the MDR or the IVDR. This means that devices and IVDs placed on the market before the entry into force of the MDR or IVDR, as applicable, or during the transition period can continue to be made available/put into use without any limitation on time (subject to their shelf-life/expiry date).
- Do I still need to comply with the MDR post-marketing requirements?
Yes. Manufacturers of devices benefitting from the revised transition periods still need to comply with the MDR’s requirements on post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices.
- Does the transition period apply in the United Kingdom?
Changes to the MDR and IVDR automatically apply in Northern Ireland under the Northern Ireland Protocol. Devices placed on the market in Northern Ireland can therefore benefit from the extension to the transition period.
The MDR and IVDR do not apply in Great Britain (England, Scotland and Wales). However, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) confirmed certificates extended in compliance with EU rules “will also be recognized as valid for placing CE marked devices on the GB market.” This is in line with the MHRA’s plans set out in the 2023 Spring Budget. In this, the Chancellor stated the UK would move towards a system for rapid sign-off of technologies when approved by trusted regulators, including the EU. See our blog discussing the Spring Budget here.
 The Q&A states that “Even if the national derogation is limited in time or the manufacturer has been required to carry out the conformity assessment procedure within a given period of time, the device benefits from the full transitional period until 31 December 2027 or 31 December 2028, as applicable, provided the conditions set out in Article 120(3c) MDR are fulfilled. The certificate is deemed to be valid until the end of the applicable transitional period, unless it is withdrawn.”