EU Regulation 2024/1860: Key Changes for IVDR Compliance

New regulation amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR): Regulation (EU) 2024/1860: Gradual roll-out of EUDAMED, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in-vitro diagnostic medical devices.

Supply chain issues – interruption of supply or discontinuation of devices:

Article 1(1) – Amendments to Regulation (EU) 2017/745 and Article 2(1) Amendments to Regulation (EU) 2017/746

‘addition of Article 10(a) Obligations in case of interruption or discontinuation of supply of certain devices

Because of the potential harm to patients when shortages of critical devices occur, there is an amendment to Article 10 of the MDR/IVDR which adds an obligation for the manufacturer or economic operator to report an anticipated interruption or discontinuation of a device, other than a custom-made device, at least 6 months before the anticipated shortage.

The manufacturer or economic operator notifies all relevant parties in the supply chain:

• • Competent authority where the authorised representative is established, who will then report the information to the competent authorities of the other Member States and the Commission
  • Importers
  • Distributors
  • Health institutions and healthcare professionals.

This regulation applies to both MDR/IVDR approved devices and legacy devices, except custom devices.

Recommendation for customers:

The Competent Authorities will need to publish information/guidance on how to report shortages, and the date of implementation of this part of the regulation will not be enforced until January 10th, 2025. It is recommended to check relevant competent authorities websites for the process of reporting so this can be included into relevant QMS procedures.

EUDAMED Roll-Out:

Article 1(2) – Amendments to Regulation (EU) 2017/745 and Article 2(1) Amendments to Regulation (EU) 2017/746

Article 34  is amended for MDR and Article 113(3) is amended for IVDR

EUDAMED is still not fully functional, with the clinical investigations and performance studies module having significant delay. This delay is holding back the use of EUDAMED’s four functional modules and the two modules due to be fully functional this year. Considering that EUDAMED will largely support the effective and efficient implementation of Regulations (E) 2017/745 and (EU) 2017/746, it has been agreed that the use of each complete module should be allowed once they have passed an independent audit, verifying its functionality. When functional, the Commission shall inform MDCG and in turn the obligation for registration of the device begins.

The deadlines for registration are:

• • For medical devices, other than custom-made devices, and for legacy devices placed on the market pursuant to Article 120(3), this deadline is 12 months from the date of publication of functionality. IVD’s must be registered no later than 6 months from the date of publication.
  • When a PSUR needs to be submitted or a serious incident of field safety corrective action reported, the device in relation to the vigilance reporting needs to be registered in EUDAMED (exemption of legacy medical devices).

Recommendation for customers:

It is highly recommended to start registering products in EUDAMED now to ensure there is no delay or issue meeting the deadline when the device module becomes functional. This is also important in case vigilance reporting is necessary or a PSUR is due.

IVD transition extension:

Article 2(3) – Amendments to Regulation (EU) 2017/746

The IVDR transition period is extended for legacy devices already certified under Directive 98/79/EC– not those new to the market or Class A non-sterile devices which have already had to comply with the IVDR on it’s original  . Devices that have been withdrawn from the IVDD certification scope cannot benefit from the new transitional provisions.

The new transitional provisions ensure continuity of supply of IVD’s in the market while giving manufacturers and Notified Bodies time to approve legacy devices under the IVDR. Legacy IVDs manufacturers must have a signed agreement with their Notified Body for conformity assessment and lodged an application for certification for IVDR certification. They must also have implemented QMS requirements as per IVDR before 26 May 2025.

Recommendation for customers:

While the extension to the transition timelines is welcome for IVD’s it is important for manufacturers to continue working towards transition to avoid Notified Bodies being overloaded with review and certification at the new deadlines.

You can read the full document for Regulation (EU) 2024/1860 on the European Association of Medical Devices Notified Bodies website.

_____________________________________________

If you have any questions about Regulation (EU) 2024/1860 for IVDR medical devices, contact us so our regulatory team can help you.

Learn how MedEnvoy can assist you:

• • EU Authorized Representative
  • EU Regulatory Importer
  • RA Consulting
  • EUDAMED Registration