The EU Regulation 2024/1860, published in the Official Journal of the European Union on July 9, 2024, introduces significant amendments to Regulations (EU) 2017/745 and 2017/746. These amendments include new provisions for the use of the European Database on Medical Devices (EUDAMED) and additional obligations for manufacturers, as explained by Alessandra Basilisco, Biomedical Engineer, Office III – Medical Devices and Active Implantable Medical Devices, Directorate General of Medical Devices and Pharmaceutical Services, Ministry of Health, during the AboutMedicalDevices conference.
Article 10a of EU Regulation 2024/1860
One of the most significant updates is Article 10a, which establishes the obligation for manufacturers to notify at least six months in advance of any potential disruptions or cessations in the supply of medical devices. This obligation applies in cases of risk of serious harm to patients or public health and involves:
- Economic operators receiving the devices.
- Healthcare professionals.
- Competent authorities, which must in turn inform the European Commission and Member States.
In Italy, upon receiving notification of the future unavailability of a device, the competent authority must:
- Identify alternatives in the Italian market with the support of the national database.
- Verify the availability of new suppliers for the production of the device.
If a device lacks CE certification under the regulation but the manufacturer is willing to continue production, exemptions may be granted for essential devices, such as life-saving ones. These exemptions require confirmation of necessity by health authorities.
The Italian Classification and EMDN
Another key aspect of the regulation is the classification system for medical devices. The Medical Device Coordination Group (MDCG) selected the Italian National Classification of Medical Devices (CND) as the basis for developing the European Medical Device Nomenclature (EMDN) due to its structure, methodology, and usability.
On May 4, 2021, the final official Italian version of the EMDN and a draft of the English version were published. Italy is responsible for the continuous updates of the European nomenclature. In December 2024, the MDCG will discuss a revision of the EMDN, introducing new codes for devices categorized under “others” (code 99).
The changes introduced by Regulation 2024/1860 represent a significant step forward in the management and transparency of the medical device market within the European Union. The adoption of the Italian classification as the European reference strengthens Italy’s role in sector regulation and accelerates the implementation of EUDAMED, ensuring more effective oversight and enhanced patient safety.
Changes for In Vitro Diagnostic Devices (IVD)
The EU Regulation 2024/1860 introduces significant changes for in vitro diagnostic devices (IVD) with the aim of ensuring continuity of supply in the European market, as outlined by Gloria Ippoliti, Office IV – In Vitro Diagnostic Devices, Directorate General of Medical Devices and Pharmaceutical Services, Ministry of Health.
Key Updates:
- Certificate validity and supply continuity
The regulation adjusts the validity of certificates issued under Directive 98/79/EC to align with new market requirements. One of the most significant changes introduces the obligation for manufacturers to notify in advance of any disruptions or cessations in the supply of devices that could pose serious risks to patients or public health. This measure aims to prevent critical interruptions in the availability of essential devices. - Mandatory use of EUDAMED and extension for “in-house” devices
The regulation also modifies the provisions regarding the mandatory use of the EUDAMED database for devices compliant with the IVDR. For “in-house” devices, the requirement to document the absence of equivalent alternatives on the market has been postponed to December 31, 2030. This extension gives healthcare operators additional time to adapt to the new regulations.
Manufacturer Awareness and Challenges for Italian SMEs
Among IVD manufacturers, there is a growing awareness of the new regulation, reflected in an increase in requests for clarification directed to notified bodies. However, in Italy, the IVD sector consists predominantly of small and medium-sized enterprises (SMEs) with limited resources, which may face greater challenges in adapting to the new requirements.
Certificate Validity
- Certificates issued by notified bodies under Directive 98/79/EC before May 25, 2017, remain valid until the expiration date indicated on the certificate, except for certificates issued under Annex VI of Directive 98/79/EC, which expire no later than May 27, 2025.
- Certificates issued by notified bodies under Directive 98/79/EC starting from May 25, 2017, that were still valid as of May 26, 2022, and have not been subsequently revoked, remain valid beyond their expiration date until December 31, 2027.
- Certificates issued under Directive 98/79/EC starting from May 25, 2017, that were still valid as of May 26, 2022, and expired before July 9, 2024, are considered valid until December 31, 2027, provided one of the following conditions is met:
- a) Before the certificate’s expiration date, the manufacturer and a notified body have signed a written agreement […] for the conformity assessment of the device covered by the expired certificate or a device intended to replace it.
- b) A competent authority of an EU Member State has granted a derogation from the conformity assessment procedure under Article 54(1) of this regulation or required the manufacturer, under Article 92(1) of this regulation, to perform the applicable conformity assessment procedure.
Market Placement or Service Provision
- Devices with a certificate issued under Directive 98/79/EC […] can be placed on the market or put into service until December 31, 2027.
- Devices for which the conformity assessment procedure under Directive 98/79/EC did not require the involvement of a notified body, where a declaration of conformity was drawn up before May 26, 2022, under that directive, and where the conformity assessment procedure under IVDR requires the involvement of a notified body, can be placed on the market or put into service until the following dates:
- December 31, 2027, for Class D devices.
- December 31, 2028, for Class C devices.
- December 31, 2029, for Class B devices and Class A devices placed on the market under sterile conditions.
These provisions apply only if the following conditions are met:
a) The devices continue to comply with Directive 98/79/EC.
b) No significant changes have been made to the design or intended purpose.
c) The devices do not pose an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of public health protection.
d) By May 26, 2025, the manufacturer has established a quality management system compliant with Article 10(8) of the regulation.
e) The manufacturer or authorized representative has submitted a formal application to a notified body in accordance with Annex VII, Section 4.3, first paragraph of Regulation (EU) 2017/746, for the conformity assessment of a device or a device intended to replace it, by the following deadlines:
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- May 26, 2025, for devices with a valid certificate under IVDD issued by a notified body before May 26, 2022, and for Class D devices.
- May 26, 2026, for Class C devices.
- May 26, 2027, for Class B devices and Class A devices placed on the market under sterile conditions.
f) The notified body and the manufacturer have signed a written agreement under Annex VII, Section 4.3, second paragraph of Regulation (EU) 2017/746, by the following deadlines:
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- September 26, 2025, for devices with a valid certificate under IVDD issued by a notified body before May 26, 2022, and for Class D devices.
- September 26, 2026, for Class C devices.
- September 26, 2027, for Class B devices and Class A devices placed on the market under sterile conditions.
From May 26, 2022, the provisions of the Regulation regarding post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices replace the corresponding provisions of the IVDD.
In vitro diagnostic devices placed on the market before May 26, 2022, in compliance with the IVDD, or after May 26, 2022, during the transitional period specified in Article 110 of the IVDR, may continue to be made available or put into service without time limitations, provided their shelf life or expiry date has not been exceeded.
Manufacturers can demonstrate that their device qualifies for the extended transitional period using the following tools:
- Manufacturer’s self-declaration (Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860 – MedTech Europe).
- Confirmation letter from the Notified Body, a document outlining the agreement between the manufacturer and the notified body. Alternatively, manufacturers can provide evidence of having submitted a conformity assessment application and/or concluded a written agreement with a notified body through other means, such as copies of relevant documents.
For more details, refer to the European Commission document.
Surveillance by Notified Bodies
- The notified body that issued the certificate under Directive 98/79/EC remains responsible for the appropriate surveillance of applicable requirements for the devices it certified, unless the manufacturer has agreed with a notified body designated under the IVDR that the latter will take over the surveillance.
- By September 26, 2025, the notified body that signed the written agreement under Article 110, paragraph 3 quarter, letter f), of the IVDR, becomes responsible for the surveillance of the devices covered by the agreement. If the written agreement concerns a device intended to replace a device certified under Directive 98/79/EC, surveillance will be conducted on the device being replaced.
- The procedures for transferring surveillance responsibility from the notified body that issued the certificate to the notified body designated under the IVDR are clearly defined in an agreement between the manufacturer and the IVDR-designated notified body, and, if possible, the notified body that issued the certificate.
- The notified body designated under the IVDR is not responsible for conformity assessment activities performed by the notified body that issued the original certificate.
A European Commission guide with Q&A on the practical aspects of implementing the extended IVDR transition period is available at this link.
Aglatech14 ContenTalkers
Laura Legnani – Marketing Services Manager
