On 16 December 2025, the European Commission (EC) published the long-awaited Proposal1, to simplify the Medical Devices Regulation (MDR) and the In Vitro Devices Regulation (IVDR) (Simplification Proposal).
On 12 December 2025, the EC had already published a Proposal2 for a draft Implementing Regulation on quality management and procedural requirements for Notified Body (NB) conformity assessment activities (NB Proposal).
In general, the aim of these Proposals is to streamline procedures, alleviate the administrative burden and to increase the transparency surrounding the services offered by NB. The Proposals should address certification bottlenecks, device shortages and reduced innovation.
These Proposals are a response to several persistent points of feedback on the MDR & the IVDR. Both industry stakeholders and EU Member States, had identified concerns about the high complexity, excessive costs and unpredictability of the current framework.
Below, we provide an overview of the proposed amendments of the MDR/IVDR Simplification. We will delve into each topic in the coming weeks.
The Simplification Proposal still needs to go through the legislative process with the Council of the EU (Consilium) and the European Parliament (EP). As such, the Proposal may be subject to amendments before being adopted.
The Proposal could be adopted as early as first quarter (Q1) of 2026 and as late as the third quarter (Q3) of 2027. In principle, adoption is anticipated by summer 2026.
1. Proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I.
2. Proposal for a Commission Implementing Regulation laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council
A. The EC conducted a targeted evaluation of the MDR&IVDR
The MDR and the IVDR became applicable in 2021 and 2022. Since, there has been a steep learning process for all the stakeholders involved. This included national competent authorities and the EC, as well as NB, manufacturers and other economic operators.
The certification bottlenecks, ultimately, led to the adoption of extended transitional periods.
The European Commission conducted a targeted evaluation of the MDR&IVDR framework. It found that there are persistent challenges concerning:
- Device shortages, including especially niche and innovative devices;
- Market competition, including especially, for SMEs;
- Market innovation, as some devices are coming to the market with significant delays or are even completely withdrawn.
To address these challenges, the EC is proposing the below amendments to the MDR, the IVDR and also the AI Regulation. We provide more information on the proposed changes to the AI Regulation here.
B. The Proposal introduces a set of targeted reforms aimed at addressing key challenges that have emerged during the implementation of the MDR and IVDR.
The Proposal is structured around eight key areas of reform, each addressing specific challenges that have emerged in the implementation of the MDR and IVDR.
For each of these topics, the EC puts forward concrete measures aimed at easing requirements, reducing administrative burdens and enhancing the predictability of the regulatory framework. The goal is also to support innovation, ensure the continued availability of devices and promote greater harmonisation across the European Union.
Some of the highlights are:
- Micro and small enterprises may use an external PRRC who needs to be ‘available’ rather than ‘permanently and continuously’ present;
- Manufacturing in-house IVDs will no longer be limited to cases where there is no suitable alternative on the market and such “homebrews” would be available to share with other hospitals;
- The categories of acceptable evidence, which may be especially relevant for legacy devices, will be expanded to include more sources;
- (In vitro) Medical Device cybersecurity requirements will be clarified and incident notification would become mandatory;
- Software classification rules would be simplified, with software being Class I by default unless it informs or drives clinical management in serious or critical situations.
The following sections outline, for each area, the main new features introduced, the issues identified and the solutions or adjustments proposed in the text.
C. Overview of main topics
Person responsible for regulatory compliance (PRRC)
The detailed qualification requirements for the PRRC will be removed.
For micro and small enterprises, the requirement for a PRRC to be permanently and continuously available is replaced by a requirement for the PRRC to be “available”.
SMEs
SMEs benefit more broadly from eased regulatory obligations (for example, audits, fees), reflecting their role in innovation and device availability.
Notified Bodies (NB)
Clarified and streamlined role for low- and medium-risk devices. Remote audits, reduced frequency, limitation of unannounced audits. Structured dialogue with manufacturers.
(Re-)certification & audits
Certificates of Conformity could be valid for more than the current limitation of 5 years.
- Simplified rules for repackaging and relabelling, including the removal of the requirement for a notified body certificate and prior notification obligations for these activities
- Targeted adaptations of classification rules, resulting in lower risk classifications for certain devices, such as reusable surgical instruments, accessories to active implantable devices and certain software
Classification rules
Targeted adaptations allowing certain devices (reusable surgical instruments, active implant accessories, certain software) to be reclassified into lower risk classes.
Periodic Safety Update Reports (PSUR) updates
Reduced frequency of PSUR: every two years for class IIb/III devices, and “as necessary” for class IIa devices, lessening administrative burden.
Summary of Safety and (Clinical) Performance (SS(C)P)
The obligation to provide an SS(C)P is limited to devices requiring notified body technical documentation assessment. The draft SS(C)P is included in the documentation submitted to the notified body, removing the need for a separate validation step.
Clinical and non-clinical data
Greater flexibility in the use of clinical and non-clinical data, including increased reliance on non-clinical evidence and new approach methodologies. The use of ‘New Approach Methodologies’, such as in silico testing, is promoted.
A definition of “well-established technology” would be introduced.
In-house devices
The conditions for the exemption will be simplified: in-house manufactured devices may be shared between healthcare institutions, without the requirement to demonstrate absence of market alternatives for IVDs.
Breakthrough & orphan devices
Creation of specific categories with accelerated procedures, possibility of conditional certification and post-market follow-up mechanisms.
Digitalisation
Mandatory electronic submission of all documents and information under the MDR/IVDR. Possibility to provide the EU Declaration of Conformity and labelling in digital format. Digitalisation of conformity and reporting processes, including for cybersecurity incidents.
Eudamed
Enhanced interoperability and reinforced use of Eudamed. Clarification of UDI assignment and registration rules. Possibility for certain electronic systems to be interoperable with Eudamed rather than fully integrated.
Notified Bodies Coordination Group for Medical Devices (NBCG-Med)
Its role will be strengthened: mandatory participation of all notified bodies, direct reporting to the MDCG, adoption of a code of conduct to harmonise practices.
European Medicines Agency (EMA)
Expanded involvement: scientific, technical and administrative support, assistance to SMEs, access to Eudamed.
Helsinki procedure
Formalisation of the Helsinki Procedure for coordination on product qualification and classification, including the option to seek expert panel opinions.
International cooperation
Introduction of reliance and mutual recognition mechanisms with third countries, active participation in international initiatives (IMDRF, MDSAP), regulatory convergence.
Cybersecurity
Clarification of requirements, mandatory notification of major incidents, alignment with the Cyber Resilience Act, involvement of CSIRTs and ENISA. Cybersecurity integrated into general safety and performance requirements.
Combined studies
Coordinated procedures for studies involving medicines, devices and diagnostics, with single submission and joint assessment.
_11zon.jpg?crop=300,495&format=webply&auto=webp)
_11zon.jpg?crop=300,495&format=webply&auto=webp)
.jpg?crop=300,495&format=webply&auto=webp)
