This article is the fourth part of the series of blog posts entitled “What’s changing in 2025”, in which the experts from the Product Law Firm team summarize the relevant topics from their respective areas of expertise. Here, we first highlight the effects of the 3rd amending Regulation (EU) 2024/1860 to the MDR/IVDR (see A.) and the implementation of the German Medical Research Act (see B.). We report on the current status of the legislative process for the European Health Data Space (see C.) and provide an overview of the Data Act (see D.), the implementation of the AI Regulation in the medical device sector (see E.), the introduction of the electronic patient file (see F.) and the innovations for digital health applications (see G.).”
A. New information obligations for medical device and IVD manufacturers
In 2025, there will be several relevant developments relating to MDR.
I. Art. 10a MDR/IVDR
Already since 10.01.2025, manufacturers of medical devices and in-vitro diagnostics have been subject to new information obligations in the event of interruption or termination of the supply of certain products. The regulations were introduced with the 3rd Amendment Regulation (EU) 2024/1860 in the new Art. 10a Regulation (EU) 2017/745 (“MDR”) and in Art. 10a Regulation (EU) 2017/746 (“IVDR”) with identical wording.
Accordingly, manufacturers of medical devices and in vitro diagnostics must, in accordance with Art. 10a para. 1 subpara. 1 MDR/IVDR, inform (1.) the competent authority at their registered office or (for manufacturers outside the EU) at the registered office of the authorized representative and (2.) all economic operators, healthcare institutions and healthcare professionals to whom the manufacturer “directly supplies the device” if they expect the supply of certain devices to be interrupted or terminated. The information obligations apply (only) to products for which it is “reasonably foreseeable” that the interruption or termination of supply may result in “serious harm or a risk of serious harm to patients or public health in one or more Member States”. According to the Q&A published by the Commission on Art. 10a MDR/IVDR (Rev 1, as of December 2024), an interruption of supply should be given regularly (“as a general indication”) from an expected inability of the manufacturer to supply for more than 60 days; however, according to the Q&A, a shorter duration may also be reportable as an “interruption” if, according to the manufacturer’s assessment, there is a risk of serious harm.
The information must be submitted at least 6 months before the expected interruption or termination, unless there are “exceptional circumstances” – i.e. if the reasons for the interruption or termination of the supply only become known to the manufacturer at shorter notice. MDCG 2024-16 publishes a notification form together with a Device Identification Table in the Annex for manufacturers to submit electronically to the national competent authority.
The competent authority (in Germany the Federal Institute for Drugs and Medical Devices (BfArM) pursuant to Section 7a MPDG in conjunction with Section 85 para. § Section 85 para. 2 sentence 1 no. 4a MPDG), informs the competent authorities of the other Member States and the Commission of the expected interruption or termination of supply (Art. 10a para. 2 MDR/IVDR). The other economic operators in the supply chain also have their own obligations: For their part, they are each obliged to inform their direct customers in the supply chain, which may consist of several stages, up to and including the healthcare facilities and healthcare professionals affected by the interruption or termination of supply (Art. 10a para. 3 MDR/IVDR).
Since 10.01.2025, manufacturers have been required to implement appropriate processes in their quality management system to fulfill any information obligations. It is foreseeable that notified bodies and certification bodies will pay attention to this during audits.
Further reading: Handorn, Neue Informationspflichten bei Unterbrechung oder Beendigung der Lieferung bestimmter Medizinprodukte gemäß Art. 10 a MDR, MPR 2024, 225 ff.
II. Gradual obligation to use EUDAMED
The 3rd Amendment Regulation (EU) 2024/1860 paved the way for the gradual entry into force of the provisions on the European database for medical devices – EUDAMED. The amended Art. 34 MDR now enables the gradual mandatory use of individual electronic systems in EUDAMED, in deviation from the original regulation. As soon as each individual module has been tested and the Commission confirms its functionality, the module will be published in the Official Journal of the EU. The current timetable (as of December 2024) envisages that the functionality of the modules for the registration of economic operators and UDI/product registration, for notified bodies and certificates as well as for market surveillance will be published in the Official Journal in mid-2025; 6 months later (i.e. at the beginning of 2026), their use will become mandatory under European law (Art. 123 para. 3 lit. d MDR new version). Manufacturers have a period of 12 months to register legacy products and MDR products that are placed on the market from 6 months after publication (Art. 123 para. 3 lit. e MDR new version).
The Q&A Gradual Roll-Out of EUDAMED published by the Commission (as of November 2024) provides guidance for economic operators and notified bodies on gradual implementation.
III. Targeted evalutation of the MDR
After the reform is before the reform. On 12.12.2024, the EU Commission launched the targeted evaluation of the MDR (EU rules on medical devices and in vitro diagnostics – targeted evaluation). This is intended to take stock of the provisions of the MDR and IVDR – which are still in the transitional stage – and assess whether they are effective, efficient and proportionate. The opportunity to participate in the targeted evaluation with submissions is available until 21.03.2025. Adoption by the Commission is currently scheduled for the 4th quarter of 2025.
In addition to the reforms that are expected (and often necessary) in the longer term, measures can be expected in 2025 that fall under the banner of reducing bureaucracy and envisage short-term, consensus-based corrections to the MDR and IVDR. For example, the possible extension and reclassification of so-called well-established technologies within the meaning of Art. 52 para. 5 and Art. 61 para. 8 MDR. The Commission has currently announced a public consultation on reclassification.
B. Implentation of the Medical Research Act
At national level, the practical implementation of the Medical Research Act of 30.10.2024 is due in 2025. The focus will be on pharmaceutical research. At the same time, research with medical devices is to be facilitated in certain areas.
I. Pharmaceutical Act
The German Pharmaceutical Act (AMG) is amended by the Medical Research Act in the following points in particular:
- Recognition of third country inspections as GMP-compliant
- Extension of the authority of the Federal Ministry of Health (BMG) to issue ordinances to change responsibilities
- Creation of an authorization basis for recommendations on the interpretation of EU principles and guidelines of good manufacturing practice (GMP) to support harmonization in the field of advanced therapies
- Establishment of an indication-based register of advanced therapy medicinal products
- Creation of a specialized ethics committee for special procedures
- Introduction of (generally binding, but mutually derogable) standard contractual clauses for clinical trials contracts for medicinal products by means of a statutory order, which is expected to be published in 2025.
II. Medical Devices Implementation Act (MPDG)
In particular, the following changes have been made to the MPDG by the Medical Research Act:
- Implementation of the information requirements of Art. 10a MDR. Accordingly, notifications to the competent authority must be made electronically in machine-readable form to the competent higher federal authority (the BfArM pursuant to Section 85 (2) sentence 1 no. 4a MPDG) (Section 7a MPDG, entered into force on 10.01.2025).
- Authorization to issue ordinances pursuant to Section 31c MPDG on mandatory standard contractual clauses for the conduct of clinical trials and performance studies. Party agreements deviating from these standard contractual clauses should be possible, just as in the area of clinical drug trials. The promulgation of the ordinance on standard contractual clauses for clinical trials with medical devices is also expected in 2025.
- Issuance of guidelines for the assessment of clinical trials and performance studies by the Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK – https://www.akek.de/) in accordance with Section 32a MPDG.
- Responsibility of specialized ethics committees according to AMG for performance studies with companion diagnostics according to Section 33 para. 1 no. 4 and 5 MPDG (enter into force on 01.07.2025).
- For other clinical trials within the meaning of Section 3 No. 4 MPDG, the requirements for the sponsor pursuant to Section 25 MPDG and for the designation of the investigator pursuant to Section 30 MPDG (Section 47 (3) MPDG new) are waived for PMCF trials of CE-marked medical devices within their intended purpose that are not additionally burdensome; this at least partially remedies the misguided inferiority in the area of other clinical trials compared to PMCF trials for conformity assessment purposes.
III. Radiation Protection Act
The amendments to the MFG will also simplify the approval procedure under radiation protection law and integrate the notification and approval procedure under radiation protection law into the approval procedure for clinical trials under pharmaceutical and medical device law.
C. European Health Data Space (“EHDS”) – Current status of the legislation process
On 24.04.2024, the European Parliament and the Council reached a political agreement on the Commission’s proposal on the European Health Data Space (EHDS).
The aim of the planned Regulation on the EHDS (EHDS Regulation-E) is to strengthen the interconnection of national healthcare systems through the secure and efficient exchange of health data for primary and secondary use: to give individuals access and control over their electronic health data, to promote the internal market for digital health services and products and to ensure a uniform framework for the use of health data for (also commercial) research, innovation, policy-making and regulation.
Member states can provide for a specific right to object to the processing of personal electronic health data recorded in EHR systems for primary use (Art. 10 EHDS Regulation, cf. in Germany already the opt-out options under DigiG). For secondary use, the EHDS provides for a right to object at European level (Art. 71 EHDS Regulation), whereby Member States can regulate exceptions to this opt-out at secondary use level under certain conditions (Art. 71 (4) EHDS Regulation).
From a product law perspective, the conformity assessment and CE marking of so-called EHR systems (electronic health record systems) within the meaning of Art. 2 para. 2 lit. k EHDS-DR: EHR systems will in future be subject to CE harmonization provisions and a dedicated concept of economic operators (Art. 25 et seq. EHDS-DR). The interfaces to medical devices, IVDs and AI systems, which are extremely important in practice, are regulated in Art. 27 EHDS-D as a supplementary conformity assessment of essential requirements in accordance with Annex II Section 2 EHDS-D. For wellness applications within the meaning of Art. 2 para. 2 lit. ab EHDS-DR, Art. 47 et seq. EHDS Regulation now also provide for mandatory requirements for interoperability with EHR systems. Manufacturers of EHDS systems and wellness applications as well as other relevant economic operators should prepare for the upcoming product law requirements at an early stage. The overlaps and additional requirements for digitalized medical devices and IVDs are also evident.
The EHDS Regulation has yet to be published in the Official Journal of the EU. The EHDS will then enter into force 20 days after publication in the Official Journal. The date of application is generally 2 years after entry into force with further differentiated transitional provisions of 4 to 10 years (Art. 105 EHDS-VO-E).
D. Data Act
With the Data Act (Regulation (EU) 2023/2854) coming into force in January 2024, a legal framework for fair access to and fair use of data was created. The rules must then be applied on a binding basis from 12.09.2025.
According to Recital 14 of the Data Act, medical and healthcare products also expressly fall within the scope of the Act. Medical device manufacturers and companies that offer data processing services (e.g. operators of DiGAs) are affected.
The Data Act is intended to grant users free access to the data generated by their use of the product or service. Manufacturers of medical devices are to be obliged to disclose all this data. In this context, manufacturers will also be subject to extensive disclosure obligations. They must provide information on what data is generated and to what extent, whether this is done continuously and in real time and how users can access the data. The data should be provided in a fair and non-discriminatory manner. To this end, the data recipient and data sender should conclude contracts.
The most important implications for manufacturers:
- Products must be modified to offer interfaces that meet interoperability specifications and provide data continuously and in real time.
- The requirements for IT security are now significantly higher.
- There is an increased risk that competitors will exploit the data.
- Costs will rise due to free use. Compensation is only permitted if it is proportionate and the data sender does not make a profit.
The Data Act also contains provisions regarding the provision of data to public bodies, but only in the event of an exceptional need.
E. Artificial Intellegince Act (AIA)
On 01.08.2024, Regulation (EU) 2024/1689 laying down harmonized rules on artificial intelligence (“AIA”) entered into force. It is the world’s first AI law and provides the European legal framework for the development, placing on the market, commissioning and use of artificial intelligence in the Union.
The AIA standardizes a product safety law specific to AI systems across all products (CE legal act). In the area of medical devices, the AI Regulation will in future supplement the sectorally regulated basic safety and performance requirements.
AI-based medical device software will practically always be classified as a high-risk AI system within the meaning of Art. 6 para. 1 in conjunction with Annex I AIA. Accordingly, an AI system is considered a high-risk AI system if (a) it is intended to be used as a safety component for a device or is itself a device and (b) the device falls under the legal acts listed in Annex I and must subsequently undergo a conformity assessment by a third party. Art. 6 para. 1 AIA refers to the EU regulations on existing product safety law listed in Annex I and thus in particular to the MDR and the IVDR. Whether a smart medical device is therefore to be classified as a high-risk AI system depends crucially on the risk classification according to the MDR, which (namely via the misclassification rule 11 in Annex VIII MDR) practically always leads to the involvement of a notified body in the conformity assessment. As a result, the requirements of the AI Regulation for high-risk AI systems will have to be applied as part of a uniform conformity assessment procedure for AI medical devices. However, the complex interplay between the requirements of the MDR/IVDR on the one hand and the AI Regulation on the other is still uncoordinated or unclear in many areas.
The AI Regulation will generally come into force on 02.08.2026. The central classification rules and requirements for high-risk AI systems in accordance with Art. 6 para. 1 AI Regulation will apply from 02.08.2027. Manufacturers of digitalized medical devices and IVDs already have to deal with the complex additional requirements of the AI Regulation, particularly in the context of development and conformity assessment.
A first MDCG document on the interplay between MDR/IVDR and the AI Regulation (“FAQ on interplay between MDR/IVDR and AIA”) is expected early in the first quarter of 2025. In addition, following a consultation carried out at the end of 2024, an EU guideline on the central definition of the AI system and on prohibited practices within the meaning of the AI Regulation has been announced for the first quarter of 2025.
F. Digital Act (DigiG)- Electronic patient file (ePA)
The “Act to Accelerate the Digitalization of the Healthcare System” (“Digital Act”, “DigiG” for short) came into force in March 2024.
The core element of the DigiG is the introduction of the electronic patient file (ePA). As is known, the nationwide roll-out of the ePA originally planned for 15.01.2025 has been delayed, so that the ePA will initially be tested in a four-week pilot phase in Hamburg, Franconia and North Rhine-Westphalia from 15.01.2025. The nationwide roll-out is therefore not expected until after the pilot phase at the earliest, i.e. from mid-February.
The “ePA for all” is designed as an opt-out model and will therefore be available to all insured persons who do not object. After the roll-out, further content such as the digital medication process and laboratory findings will be gradually integrated. It should also be possible to release the data stored in the ePA for research purposes in the course of the year; an opt-out solution is also planned for this.
G. Digital health applications – DiGA
There will also be some relevant developments for DiGA in 2025. Originally, it was planned that DiGA could only be prescribed via e-prescription from 01.01.2025. This timetable was not adhered to, in particular due to concerns on the part of manufacturers. One of the criticisms was that the e-prescription app required to activate DiGA is currently not used by most insured persons. Nevertheless, the planned switch to exclusively electronic DiGA prescriptions should take place in the course of 2025.
According to the DigiG, the pricing of DiGA is to be more closely aligned with success criteria in future. From January 1, 2026, at least 20 percent of the permanent reimbursement amount for DiGA is to be performance-based, meaning that the National Association of Statutory Health Insurance Funds and the manufacturers’ associations will have to reach corresponding agreements in 2025. It will also be important to observe this year whether the first digital nursing application (DiPA) finally successfully completes the application process and is included in the DiPA directory
Do you have any questions about this news or would you like to discuss it with the author? Please contact: Dr. Boris Handorn and Anna Christ
