New Regulation (EC) 2024/1860 amending (EU) 2017/745 and (EU) 2017/42
11 July 2024
On 9 July 2024, a new Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) was published in the Official Journal of the European Union. The amendment deals with:
- phased introduction of Eudamed;
- new obligations for manufacturers and economic operators to inform about supply chain disruptions, device discontinuation or potential associated risks;
- extension of the transition period for specific in-vitro diagnostics (IVDs).
1. Gradual phase-out of Eudamed
The Eudamed database will come into operation module by module with the entry into force of Regulation (EU) 2024/1860:
- Legacy or compliant devices must be registered within 12 months of the publication of the module functionality notice.
- The registration of certificates by notified bodies is to be done within 18 months repectively.
2. Obligation to report supply chain disruptions
According to Amendment (EU) 204/1860, manufacturers and economic operators are obliged to inform about interruption or discontinuation in supply chain 6 month before the expected interruption or discontinuation, and specify the reason.
In cases when the device is of high importance for the provision of health services, when there are no alternatives on the market and the duration of the interruption could become critical and result in serious harm or risk of serious harm to patients and/or public health in one or more Member States, the manufacturer should immediately inform the competent authorities of each Member State as well as the economic operators, healthcare institutions and healthcare professionals directly affected by an interruption or discontinuation of the supply chain according to Article 10a (3) MDR. Manufacturers of custom-made devices are excluded from this obligation. The MDCG is currently preparing a guideline to clarify when reporting is required under Article 10a MDR.
3. Extension of the transition period for in vitro diagnostics (IVDs)
The amendment concerning the IVDR transitional provision only applies to devices for which a confirmty assessment under IVDR by a notified body is required. The periods during which devices may continue to be placed on the market can be extended by two years if the manufacturer fulfild the following criteria:
- The manufacturer needs to have established a QMS system in accordance with Article 10 of the IVDR before 26 May 2025 and maintain it continuosly.
- The manufacturer should have submitted a formal application for certification to a notified bodyy. Here the deadline depends on the risk class of the device.
- The manufacturer needs to have signed a contract with the notified body cevering concerned devices.
Furthermore, devices must:
- be compliant with the directive requirements;
- not have undergone any significant changes in design or intended purpose (must be proven);
- not present a risk of health or safety for patients, users and others.
With regard to existing certificates for IVDs, devices covered by a valid certificate will continue to be monitored by notified bodies. Audits will be carried out in accordance with the IVDD until the end of the transition period.
Regulation (EU) 2024/1860 provides that notified bodies performing the conformity assessment procedure under IVDD will be responsible for the surveillance until 26 September 2025 at the latest.
