While the goals of the currently applicable regulations from 2017 – improved patient safety and higher product quality – are fully supported by businesses, the detailed and complex requirements pose significant challenges to companies. Certification procedures for medical devices often take more than a year now, and costs have multiplied for many manufacturers. This applies to both established existing products and innovative new developments. The competitiveness of the medical technology sector in Europe is negatively affected, and supply security is partially endangered.
In response, the EU Commission proposed a reform of the Medical Devices Regulation and In-vitro Diagnostics Regulation at the end of 2025, aiming to address these issues. The DIHK fundamentally supports the reform approaches but sees further action needed.
Essential Information in Brief
The reform proposals from the EU Commission issued in December 2025 include essential steps aimed at reducing burdens for the industry and promoting the proper function of the European market while maintaining patient safety and product quality.
From the perspective of the German Chamber of Commerce and Industry (IHK), the introduction of permanent certificate validity through the removal of the rigid five-year limit, reduced costs for small and micro enterprises, ease of compliance for SMEs by lowering requirements for the responsible person, flexibility in clinical requirements, extended use of non-clinical data, expedited processes for breakthrough and orphan devices, along with greater digitisation, are seen positively.
DIHK demands
According to the DIHK, additional measures should focus on the following aspects:
- Extend cost relief: The proposed fee reductions for certifications should include all small and medium-sized enterprises (SMEs) with up to 250 employees.
- Introduce binding processing timelines and standard fees: Designated bodies should publish EU-wide deadlines and comprehensible standard fees for mandatory services, allowing manufacturers to better plan and calculate procedures.
- Reduce redundant technical documentation: Technical documentation serves as the primary evidence of a medical device's safety and performance. Since 2017, its complexity has significantly increased, imposing major administrative burdens on SMEs. Efficient adjustments should be made, eliminating redundancies. Currently, the same information must be entirely repeated in up to ten different documents – cross-references to existing reports should be allowed again.
- Cover proven technologies more broadly: The new concept for products with proven technology, i.e., with long-established safety records, should rely not only on risk class but also on technological maturity, encompassing generic product groups like orthoses, prosthetics, hearing aids, or contact lenses.
- Make recertification risk-based: For unchanged products, re-evaluations of technical documentation should no longer be standard practice; rather, a risk-based streamlined evaluation procedure should be adopted.
- Prevent duplication with AI regulation: For AI-based medical devices, the Medical Devices Regulation should remain the sole applicable framework. Manufacturers should undergo only one integrated conformity assessment procedure.
- Create central reporting channels: Reports should exclusively be submitted to a central entity: the European Database for Medical Devices (EUDAMED). System-level data exchange between authorities and designated bodies should be established.
- Enhance international recognition: Duplicate certifications for non-EU markets should be minimized through mutual recognition mechanisms. At the same time, national authorities within the EU should not practically re-examine CE certificates.
- Furthermore, the swift adoption and implementation of the reform proposals are crucial to avoid market uncertainties, competitive disadvantages, and potential supply chain gaps due to the expiry of transitional deadlines for certificates in late 2027 and 2028.
FAQ
Frequently Asked Questions
What are "Notified Bodies" – and why are there such long waiting times?
Notified Bodies are private companies accredited by national authorities to carry out conformity assessments for medical devices. Since the introduction of the new regulations, their capacities have not kept pace with a sharply increased demand and the associated workload – causing manufacturers to wait sometimes more than a year to complete certification procedures. Additionally, the bodies interpret requirements differently, which creates significant legal uncertainty for manufacturers operating in several EU countries.
What specifically changes with recertification?
Currently, certificates must be completely renewed every five years – an elaborate and costly process. The reform proposal aims to eliminate this rigid deadline: Certificates will generally remain valid indefinitely as long as regular inspections reveal no objections. However, the specifics of these inspections are still unclear – and will determine whether the simplifications are effective in practice.
Does the reform also affect me if I manufacture software or AI products for the medical field?
Yes – and the regulatory situation is particularly complex in this area. Medical software and AI-based applications may simultaneously fall under the Medical Device Regulation and the European AI Regulation. The German Chamber of Commerce and Industry (DIHK) advocates for the future implementation of only one integrated procedure for such products. The Notified Body accredited for the Medical Device Regulation will be responsible in this case.
What happens to my existing certificates if the reform does not come in time?
In late 2027 and 2028, transitional periods will expire under which certificates granted under old regulations remain valid. For products that are not recertified under the new regulations by that time, approval gaps could arise, and in the worst-case scenario, they might have to be withdrawn from the market. This could lead to tangible supply shortages.
Download
The DIHK statement dated July 31, 2026, on the proposal for a regulation amending the EU Medical Devices Regulation and the EU In-vitro Diagnostics Regulation and other regulations is available here:
260731_DIHK Stellungnahme MDR IVDR_NEU (PDF, 196 KB) (only available in German)
- Relevant in topic:
- Innovation and Digitalisation
- Key areas:
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- Health
- Industry
It has been translated with the assistance of AI.
No guarantee is made as to the accuracy or completeness of the translation.
Released 31.07.2026
Modified 08.09.2026
Contact
Natascha Waltke
Director Economy and Human Rights