European Commission has proposed a new regulation to amend the current MDR and IVDR with the aim of preventing potential interruption in the supply chain. While this proposal impacts both MDR and IVDR economic operators, its implications are even broader for those operating in the IVD industry.
1. Prior notification mechanism: Applies to MDR and IVDR
One new introduction in this proposal is the prior notice mechanism, which requires manufacturers to inform relevant competent authorities, health institutions, or economic operators in the supplier chain about ceasing the supply of critical devices at least 6 months before cessation and specify the reasons. The reason behind this requirement is several surveys conducted by notified bodies and national competent authority, which have raised concerns about shortage of certain critical medical devices that may have serious implications for patient safety and public health,
It is noteworthy that this requirement also applies to competent authority that has received the information, which must then inform other competent authorities of member states.
The devices falling into this so-called category of critical devices are to be interpreted by the forthcoming MDCG guidance. The new MDCG guidance may consider the following factors such as the relevance of the device for ensuring essential healthcare services, the dependency of patience health and safety on the continuous availability of the device, or the absence of suitable alternatives when issuing the new guidance.
2. Start using available modules of Eudamed: Applies to MDR and IVDR
Eudamed has six modules, with the modules for Actors, UDI Database/Device and NB & Certificates already in production but are in voluntary use until now. The modules for vigilance and post-market Surveillance and Market Surveillance are expected to be completed in Q2/2024, while Clinical module will not be ready before Q3/2026 (Ref. to the EC illustration below).
According to the current MDR Article 34, the use of Eudamed becomes mandatory only after all modules are functional. However, this concept initially introduced into the MDR and IVDR has hindered the engagement of economic operators with Eudamed, for example, leading multiple registrations in national databases instead of single registration in Eudamed.
With the proposed amendment of MDR and IVDR, a gradual roll-out of Eudamed is now possible. Manufacturers, particularly those with a long list of medical devices to enter into Eudamed, should begin preparing a device registration plan and strategy to ensure a smooth and timely registration process.
This change, introduced by the new regulation, applies to all devices regardless of their marketing status. The deadline for entering these devices into Eudamed is 6 months after the date of publication of the notice in the Official Journal of the European Union. Mandatory use of existing modules Eudamed could start as early as Q4/2025.
Manufacturers should also upload the summary of safety and clinical performance (SSCP) and/or the summary of safety and performance (SSP) to Eudamed and request free sale certificate through the platform.
Notified bodies are required to ensure that the information for certificates of conformity is entered into Eudamed within 12 months after the date of publication of the notice in the official Journal of the European Union.
3. Extension of IVDR transitional timelines
Compared to the MDR transition, IVDR has introduced more significant challenges to IVDR economic operators and notified bodies due to the scope of the changes, such as new risk classification system and scrutiny procedure.
To address these challenges, a staggered extension of IVDR transitional periods was adopted in early 2022. For example, a List A device according to the IVDD, which may be a class D device according to the IVDR, can be placed on the market until 26 May 2025. However, based on conducted surveys, this timeline is considered too tight for manufacturers to demonstrate IVDR compliance, especially for class D devices used in critical applications such as testing for infections in blood or organ donations, and for blood grouping for transfusions. A shortage of such devices will pose a significant risk to public health.
To mitigate these risks, the new regulation proposes amendments to:
a) Further extend the transitional period for all risk class of IVDs.
b) Introduce the conditions to enable sufficient IVDs to continue circulating in the supply chain even after the certificates issued in accordance with IVDD expire. These conditions were adopted last year by the MDR according to Regulation 2023/607. In summary,
- Certificates validity:
- IVDD certificates issued from 25.05.2017 that were valid on 26.05.2022 and have not been withdrawn: remain valid after the expiry date on the certificate until 31.12.2027. This amendment grants additional 2 years extension period.
- IVDD certificates issued from 25.05.2017 that were valid on 26.05.2022 but have expired before entry of this amending regulation: remain valid until 31.12.2027 provided one of the following conditions is fulfilled:
- before the expiry date, the manufacturer has signed a written agreement with a notified body; or
- a competent authority has granted a derogation from the applicable conformity assessment procedure according to Article 54 or has required the manufacturer according to Article 92 (other non-compliance).
- Placing on the market and putting into service:
- Devices with a IVDD certificate: until 31.12.2027, plus the conditions below fulfilled.
- Devices without a IVDD certificate and IVDD declaration of conformity signed before 26.05.2022, and requiring the involvement of a notified body under IVDR:
- class D devices: 31.12.2027, plus the conditions below fulfilled.
- class C devices: 31.12.2028, plus the conditions below fulfilled.
- class B and A-sterile devices: 31.12.2029, plus the conditions below fulfilled
The conditions to be met in order to place devices on the market or put into service are similar to those laid down for medical devices by Regulation (EU) 2023/607 for legacy devices.
- devices continue to comply with IVDD;
- no significant changes in the design and intended purpose;
- don’t present an unacceptable risk;
- manufacturer’s QMS is in place by 26.05.2026;
- a formal IVDR application has been lodged according to the following timelines:
- devices with IVDD certificates and devices without IVDD certificates and are class D: 26.05.2025
- devices without IVDD certificates and are class C: 26.05.2026
- devices without IVDD certificates and are class B and class A-sterile: 26.05.2027
- a written agreement has been signed no later than 4 months from the timelines mentioned right above.