This article is the penultimate part of the blog series “What’s Changing in 2026,” in which the experts of the Produktkanzlei summarize key topics from their respective practice areas. Here, we examine the developments relating to the MDR, including the Commission’s draft amending regulation for the MDR/IVDR (see under A.). At the national level, we discuss the simplification of the conduct and approval of clinical investigations and performance studies (see under B.). Further topics include the Data Act (see under C), the AI Act in the medical device sector (see under D.), the rollout of the electronic patient record (see under E.), and updates regarding digital health applications (see under F.). Finally, we provide an overview of the changes in cosmetics law (see under G.).
A. MDR and IVDR
In 2026, the MDR and IVDR continue to be at the forefront of both regulatory and practical developments. The European Commission’s latest reform proposal, the expiration of transitional periods, and emerging advances in digitalization are collectively shaping the evolving regulatory landscape.
I. Draft Reform
On 16 December 2025, the Commission published a draft amending regulation for the MDR and IVDR. This proposal contains numerous, in part fundamental, adjustments. The overarching aim of the reform is to make the MDR/IVDR more efficient, transparent, and innovation‑friendly – without reducing the high standards for safety, quality, and patient protection. The primary focus is on simplifying and reducing the regulatory burden, which has proven substantial under the current framework.
The intended improvements include clearer structuring of conformity assessment procedures, increased predictability, and enhanced cost‑efficiency. For example, fee reductions may be introduced for SMEs and orphan devices, and the Commission would be empowered to define the structure and amount of such fees. A new dispute‑resolution mechanism between manufacturers and notified bodies is also planned: the authority responsible for the notified body would act as an “ombudsman” in case of disagreements.
At the same time, digitalization should be used to speed up processes and simplify communication between manufacturers, authorities and notified bodies.
To promote innovation, the draft reform provides for the introduction of so-called ‘regulatory sandboxes’. These enable manufacturers to develop, test, validate and, if necessary, use innovative products under real conditions for a certain period of time under official supervision without having to meet all regulatory requirements.
A particular focus lies on enhanced harmonization within the EU to avoid regulatory overlap and ensure a coherent framework. For instance, the MDR/IVDR and the AI Act are to be better aligned.
The draft additionally introduces new information‑sharing and cooperation obligations for Member States to mitigate structural issues related to shortages. The EMA will monitor shortages and support national authorities and the Commission. Moreover, aligned with the newly effective Article 10a MDR/IVDR (early 2025), a positive list of critical medical devices shall be established, and an IT portal for reporting supply interruptions will be created.
The public consultation runs until 16 March 2026, so comments on the draft can be submitted until then. The proposal will now be presented to the European Parliament and Council for adoption. The trilogue negotiations are planned for spring 2026. It remains to be seen whether the reform will be implemented within 2026.
II. Transition Periods
On 26 May 2026, the transitional period for custom‑made implantable Class III devices under the MDR ends.
2026 also marks the end of the IVDR transition period for Class C products, for which the involvement of a notified body was already required under the IVDD. A formal application for these products must be submitted to the notified body by 26 May 2026. As a result, a written contract with a notified body must be in place no later than four months after the application is submitted, i.e. by 26 September 2026, for these products to continue to be placed on the market.
III. Electronic Instructions for Use – eIFU
In 2025, the scope for electronic instructions for use was significantly expanded, but only for professional users, not laypersons. On 25 June 2025, the Commission adopted Implementing Regulation (EU) 2025/1234 amending Implementing Regulation (EU) 2021/2226 regarding the types of medical devices for which instructions may be provided electronically. The amending regulation provides for a significant expansion of the scope of application of electronic instructions for use (eIFU) in place of paper instructions for use, but it is still not possible to introduce eIFU across the board for products intended for use by laypersons. Implementation remains optional for manufacturers. The implementing regulation entered into force on 26 July 2025.
IV. EUDAMED
On 27 November 2025, the Commission published Decision (EU) 2025/2371 on the announcement of the functionality and fulfilment of the functional specifications of certain electronic systems contained in the European Database on Medical Devices and on the declaration of functionality of the first four modules in the Official Journal of the European Union. In accordance with the transitional provisions of Regulation (EU) 2024/1860, this marks the start of the six-month transition period.
Accordingly, the first four EUDAMED modules will become mandatory from 28 May 2026:
- Actor registration (Art. 30 MDR / Art. 27 IVDR) — already nationally mandatory in Germany since 26 May 2021
- UDI database and device registration (Art. 28–29 MDR / Art. 25–26 IVDR)
- Notified bodies and certificates (Art. 57 MDR / Art. 52 IVDR)
- Market surveillance (Art. 100 MDR / Art. 95 IVDR)
For legacy products placed on the market before 28 June 2025, an additional transition period applies: Manufacturers and distributors of systems and treatment units must have registered such existing products in the UDI/Product Module by 27 November 2026 at the latest.
B. Simplification of Clinical Investigations and Performance Studies – Standard Contractual Clauses
On 18 September 2025, the German Federal Government published the Regulation on on standard contractual clauses for the conduct of clinical trials (Standard Contractual Clauses Regulation – StandVKlV) for medicinal products. This regulation applies to contracts for clinical trials of medicinal products concluded on or after 17 December 2025.
Sec. 31c of the Medical Devices Implementation Act (MPDG) also provides for the possibility of establishing standard contractual clauses for clinical trials and performance studies by means of a statutory order for medical devices and IVDs.
The enactment of a corresponding regulation is expected in the near future in 2026. The aim is to standardise and facilitate contract negotiations for manufacturers, sponsors and trial centres.
C. Data Act
The Data Act (Regulation (EU) 2023/2854) entered into force in January 2024, establishing a legal framework for fair access to and use of data. Its provisions have been binding since 12 September 2025.
In Germany, the federal government adopted a draft bill from the Federal Ministry of Digital and Public Service Modernisation on 29 October 2025. The aim is to adapt national legislation so that the provisions of the Data Act can be enforced without hindrance and violations can be effectively sanctioned. In this respect, the designation of the Bundesnetzagentur as the competent national authority (Sec. 2 of the draft) is also of central importance.
D. Artificial Intelligence Act – AI Act
The AI Regulation will apply from 2 August 2026. The central classification rules and requirements for high-risk AI systems will only apply from 2 August 2027, in accordance with Art. 6(1) AI Act.
However, the Commission has now published a proposal for a digital omnibus regulation on AI in order to simplify and relax the rules. According to this omnibus proposal, the rigid application deadlines previously envisaged are to be replaced by a dynamic mechanism. For systems covered by Annex I AI Act, companies would be given 12 months longer to adapt to the changed legal situation. This also applies to the MDR and IVDR. However, the relevant obligations may apply earlier if the Commission confirms that sufficient measures to support compliance (such as harmonised standards and common specifications) are in place. The proposal is currently still in the legislative process – whether and in what form the changes will actually be implemented is currently open. Manufacturers should therefore not rely on this proposal, but should already start addressing the complex additional requirements of the AI Act.
Irrespective of this, structural changes for medical devices in conjunction with the AI Act are to be expected in view of the planned reform of the MDR and IVDR. The Commission’s draft MDR reform provides for the MDR and IVDR, which are currently listed in Annex I of the AI Act, to be moved to Section B. As a result, the full high-risk regime of the AI Act would no longer apply directly to medical devices and IVDs, but the application of the AI Act would be limited to the horizontal provisions referred to in Art. 2(2) AI Act. At the same time, a revision of Art. 5(8) MDR is intended to clarify that the European Commission must take into account the requirements for high-risk AI systems in accordance with Chapter III, Section 2 AI Act when drafting implementing and delegated acts. As a result, the requirements of the AI Act would not be completely eliminated, but would be systematically integrated into the MDR. In this way, the Commission aims to avoid unclear overlaps between the MDR/IVDR and the AI Act.
E. Electronic Patient Record (ePA)
Since 1 October 2025, the use of the ePA has been mandatory for all doctors in Germany.
From 1 January 2026, software systems that have received confirmation of conformity for the use of the ePA and are therefore ‘ePA-ready’ must be in use. Doctors who use systems that are not ePA-compatible or who cannot provide proof of using a compliant system risk having their fees reduced and their IT flat rate cut. To avoid hardship cases, the National Association of Statutory Health Insurance Physicians can issue corresponding interpretation guidelines.
In addition, the ePA will be supplemented by a medication plan in the course of 2026. The electronic medication plan supplements the medication list with information such as dosage and instructions for use.
F. Digital Health Applications (DiGA)
Further developments are ongoing with regard to DiGA. On 28 October 2025, the Federal Ministry of Health published a draft bill to amend the Digital Health Applications Regulation (DiGAV).
This draft amendment primarily takes into account applications that constitute an AI system in accordance with the AI Regulation. Furthermore, new regulations for the gradual implementation of the AbEM were defined on the basis of the legal requirements of SGB V.
G. Changes in Cosmetics Law
The Omnibus VI Regulation (2025/0531/COD) aims to introduce not only simplifications in chemicals legislation, but also amendments to Regulation (EC) No 1223/2009 (hereinafter “Cosmetic Regulation”). The adoption of the draft is expected later this year.
The amendments concern, among other things, a new procedure for the inclusion of additional colourants, preservatives and UV-filters in Annexes IV, V and VI of the Cosmetic Regulation. Where it can be scientifically demonstrated that the use of a substance in a cosmetic product is safe, its inclusion should be made possible through a procedure set out in a new Article 14a Cosmetic Regulation. The timeline for this procedure is intended to be accelerated through legally defined deadlines.
Art. 15 Cosmetic Regulation generally prohibits the use of substances classified as CMR under Regulation (EC) No 1272/2008 in cosmetic products. The changes introduced by Omnibus VI involve a substantial expansion of the possibilities for the exceptional use of such CMR substances.
Furthermore, the notification requirement for products containing nanomaterials within the meaning of Art. 16 (3) – (7) Cosmetic Regulation is to be removed. In addition, the glossary of ingredient names is to be abolished, with future references made directly to the International Nomenclature of Cosmetic Ingredients (INCI) in order to avoid delays in incorporating new entries into the glossary.
On 12 January 2026, Regulation (EU) 2026/78 (as part of Omnibus VIII) was adopted, amending the Cosmetic Regulation by adding newly classified CMR substances and placing them on the respective lists of prohibited, restricted or permitted substances.
Do you have any questions about this news or would you like to discuss it with the author? Please contact: Prof. Dr. Boris Handorn and Anna Christ
