MDCG 2024-5: Guidance on Investigator Brochure Minimum Contents
23 April 2024
EU Updates: MDCG Meeting on Device Shortages due to the May MDR Cutoff & New MDR/IVDR Industry Survey
26 April 2024Page edited 26 April 2024
Overview
With not much surprise, Parliament voted yes to:
- Extend the IVDR transition period for legacy devices
- Introduce a gradual rollout of EUDAMED, which will make some registration modules mandatory early
- Require manufacturers to report potential disruption to supply of critical products (including discontinuation)
The official announcement is available here. And the final text for COM(2024)43 is available here. Note that there are differences from the original January 2024 version, located here.
Timing to Amend the MDR/IVDR
Presuming no further amendments to the draft are proposed, it should be formally adopted and then published in the Official Journal of the EU (OJEU). It will enter into force on the day of its publication.
When the MDR transition period was extended, it took less than one month between Parliament’s vote and its publication in the OJEU.
New IVDR Compliance Date for Legacy Devices
The transition period has been extended to:
- Devices with IVDD 98/79/EC Notified Body Certificates – 31 December 2027
- Class D – 31 December 2027
- Class C – 31 December 2028
- Class B – 31 December 2029
- Class A sterile – 31 December 2029
The extension does not apply to:
- Class A non-sterile devices. These products already had to comply with the IVDR on its original date of application (26 May 2022).
- Devices new to the market. These must be CE Marked under the IVDR.
Eligibility Criteria & Additional Deadlines
Manufacturers of legacy devices must take the following actions:
- Devices with IVDD 98/79/EC Notified Body CE Certificates:
- Implement an IVDR-compliant QMS (Article 10(8)) by 26 May 2025
- Lodge an application with Notified Body by 26 May 2025
- Have a signed agreement with Notified Body by 26 September 2025
- Class D devices:
- Implement an IVDR-compliant QMS (Article 10(8)) by 26 May 2025
- Lodge an application with Notified Body by 26 May 2025
- Have a signed agreement with Notified Body by 26 September 2025
- Class C devices
- Implement an IVDR-compliant QMS (Article 10(8)) by 26 May 2025
- Lodge an application with Notified Body by 26 May 2026
- Have a signed agreement with Notified Body by 26 September 2026
- Class B devices
- Implement an IVDR-compliant QMS (Article 10(8)) by 26 May 2025
- Lodge an application with Notified Body by 26 May 2027
- Have a signed agreement with Notified Body by 26 September 2027
- Class A sterile devices
- Implement an IVDR-compliant QMS (Article 10(8)) by 26 May 2025
- Lodge an application with Notified Body by 26 May 2027
- Have a signed agreement with Notified Body by 26 September 2027
If they do not, as of the above deadlines, the products cease being legacy devices.
Further, the devices must:
- Continue to comply with IVDD 98/79/EC
- Not introduce any significant changes to the design or intended purpose
- Not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health
New EUDAMED Registration Deadlines
Current legislation stipulates EUDAMED will not be mandatory until all six modules are fully functional. At this time, only three of the six modules have been released. The remaining modules will not be ready for production until at least 2027.
The amended legislation changes this, so that EUDAMED no longer requires all six modules to be fully functional. Instead, each module can be rolled out on an individual basis.
Key Points
- Economic Operators and their devices will need to be registered in EUDAMED sometime in 2025-2026.
- Manufacturers with a large number of devices may need to schedule out regulatory time/resources for this task.
This requirement applies to all devices (legacy and MDR/IVDR CE Marked) except custom-made devices.
Timing
NOTE: Before its mandatory use can be published in the Official Journal of the EU (OJEU), each module must first successfully pass an independent audit, verifying it is fully functional.
- Devices must comply with the registration requirements outlined in MDR Art. 29/IVDR Art. 26, no later than 12 months from the date of publication in the OJEU.
Today’s Commission update states that use of EUDAMED is expected “from the beginning of 2026”. However, ultimately we need to watch for the audit timing + publication in OJEU + 12 months (registration). The audit could be fast tracked and then be successful on the first try; or it could be delayed if the module does not pass the initial independent audit.
An example of how the timing could occur: UDI/Devices module undergoes audit in 2024 and is deemed fully functional; this is published in the OJEU on January 1, 2025; devices must be registered by January 1, 2026.
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Obligation to Notify of Anticipated Device Shortages
Article 10 of the MDR/IVDR (Manufacturer’s obligations) will be updated. It will require that manufacturers give advance notice if they expect any interruption to the supply of critical devices. This includes discontinuation of any product lines.
Key Points
- This is required when it is reasonably foreseeable that a supply interruption may result in serious harm or a risk of serious harm to patients or public health, in one or more Member States.
- At least six (6) months’ advance notice must be given, before the anticipated interruption.
- The manufacturer should notify all relevant parties. These include, but are not limited to, their (or their Authorized Representative’s) Competent Authority, importers, distributors, health institutions, and healthcare professionals.
Manufacturers should document this requirement to ensure they can adequately comply. They should have a mechanism to asses:
- In advance, potential interruption to supply, e.g., due to supplier shortages, or other reasons why production may be scaled back.
- If this interruption may “result in serious harm or a risk of serious harm to patients or public health in one or more Member State”.
- Note: The Commission is working with the Member States and stakeholders to qualify what constitutes “serious harm or a risk of serious harm”. And therefore, will be required to notify of supply disruption.
- Who are the impacted parties, so they can be contacted.
- How they will be notified.
This requirement applies to all devices (legacy and MDR/IVDR CE Marked) except custom-made devices.
