Reform of the MDR and IVDR – A critical look at the Commission's proposal of 16 December 2025

Co-Author: Farina Simon

A. Introduction

Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) have been in force since 26 May 2021 and 26 May 2022, respectively. Overall, they impose significantly stricter requirements on medical devices and in vitro diagnostic medical devices than their predecessor regulations. 

Their aim was to create a robust, transparent, predictable and sustainable legal framework that ensures a high level of safety and health protection while promoting innovation. However, difficulties in implementing these regulations became apparent from the outset, leading to repeated extensions of the transition periods provided for in the MDR and IVDR. An initiative launched by the European Commission in 2024 to review the regulations in terms of effectiveness, efficiency, relevance and coherence assessed in particular the impact of the regulations on the development and availability of innovative products, costs, administrative burden and benefits. The public consultation conducted from December 2024 to March 2025 and the call for evidence in autumn 2025 led to findings that the Commission used as the basis for its proposal for the amendment of the MDR and IVDR, which it presented on 16 December 2025. The planned changes focus on:  

• Regulatory simplification,
• reducing administrative burdens and
• more efficient conformity assessment.
  
   

B. Overview of the most important changes

I. Regulatory simplification

• Requirements for the PRRC

The detailed qualification requirements currently set out in Article 15 MDR/IVDR for the person responsible for regulatory compliance (PRRC) are to be removed. As before, SME should be able to outsource the activities of the PRRC. However, the obligation to have the PRRC "permanently and continuously" available, will be removed. Instead, the mere availability of the external PRRC should be sufficient.

• Unlimited validity of certificates of conformity

The maximum validity period of 5 years previously provided for in Article 56(2) MDR and Article 51(2) IVDR is removed. The validity of certificates may only be limited in time in exceptional cases where the notified body considers it necessary based on duly justified grounds. In addition, notified bodies will be given the option of imposing certain conditions on the validity of the certificates of conformity, such as restricting the intended use to certain groups of patients or requiring the manufacturer to undertake specific PMCF studies. Instead of recertification, notified bodies should carry out appropriate surveillance activities during the period of validity of the certificate, including periodic and risk-adequate reviews, considering developments of the state of the art. 

• Change in classification rules

The new regulations aim to assign medical devices to lower risk classes in many cases, thereby simplifying the relevant conformity assessment procedures. The changes provided for in Annex VIII of the MDR relate in particular to classification rules 8, 9 and 11.

• Rule 8: Certain implantable devices that are well-established technology devices are to be exempted from the higher classification from class IIb to class III.  
• Rule 9: Active therapeutic devices and all active products listed in Annex XVI that are intended to administer or exchange energy should no longer be classified as class IIb but as class IIa. The only exceptions to this are devices that may administer energy to or exchange energy with the human body in a potentially hazardous way.
• Rule 11: Software intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition ("Decision Support System" – "DSS") should generally be classified as class I. However, depending on its intended purpose, classification in a higher risk class is planned if the output of the DSS is intended for a disease or condition:

• in a critical situation with a risk of causing death or an irreversible deterioration of a person's state of health. In this case it is classified as class III;
• in a serious situation with a risk of causing a serious deterioration of a person's state of health or a surgical intervention, or to drive clinical management in a critical situation. In this case it is classified as class IIb; or
• in a non-serious situation, or to drive clinical management in a serious situation or to inform clinical management in a critical or serious situation. In this case it is classified as class IIa.  

• "Well-established technology device"

The term "well-established technology device" is newly introduced. Various simplifications are planned for this product group: 

• An exception is made from the obligations laid down in Article 18 MDR (implant card and information to be supplied to the patient with an implanted device). 
• The requirement for a summary of safety and clinical performance in accordance with Article 32 MDR does not apply.
• The conformity assessment pursuant to Article 52 MDR is simplified in that the assessment of one representative device per generic device group or per each category of devices shall be sufficient for the assessment of the technical documentation.  
• No review of the periodic safety update report by the notified body is required as part of its surveillance assessment pursuant to Article 86 MDR.

• Clinical evidence/use of existing evidence

As before, the manufacturer of a device demonstrated to be equivalent to an already marketed device from another manufacturer will be allowed to refer to the clinical evidence for that product in Article 61(5) MDR. However, the previously required consent of the manufacturer of the reference product, based on a contract to be concluded between the two manufacturers, is to be omitted. Instead of express consent, the referencing manufacturer must provide the notified body with clear evidence that the clinical evaluation of the reference product has been performed in compliance with the requirements of the MDR. 

II. Reduction of administrative burden

• Summary of safety and clinical performance

The scope of devices for which the manufacturer must prepare a summary of safety and clinical performance is reduced. Only class IIb implantable devices and class III devices are covered, except for custom-made devices, investigational devices and well-established technology devices. In addition, the draft of the summary of safety and clinical performance is part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 MDR. Separate validation by the notified body is therefore no longer required. The proposed changes concern Article 32 MDR and Article 29 IVDR.

• Periodic safety update report

The frequency with which manufacturers are obliged to update the periodic safety update report will be reduced. For class IIb and class III devices a one-time update will be required one year after certification. This will be followed by updates every two years. Exceptions to the two-year cycle are provided for in cases where significant changes occur that affect the benefit-risk assessment or the acceptability of undesirable side-effects. For class IIa devices, the safety report only needs to be updated when necessary. The periodic safety update reports are part of the technical documentation and, for class III devices and class IIb implantable devices, except for well-established technology devices, their review becomes part of the surveillance assessment of the notified bodies. The changes relate to Article 86 MDR and Article 81 IVDR.

• Reporting of serious incidents in the framework of vigilance

Manufacturers will now have 30 days to report serious incidents in accordance with Article 87 MDR and Article 38 IVDR, instead of the previous 15 days. This does not apply to incidents related to public health threats, death or serious deterioration of health. 

• Changes after certification

With regard to the requirements to be met by notified bodies, in the event of changes after certification, they must distinguish between changes to the quality management system and changes to the approved device. In addition, a clear distinction must be made between changes that do not require prior notification, changes that require prior notification but not prior approval, and changes that require the approval of the notified body before they are implemented. In addition, the manufacturer is allowed to agree on a so-called "change control plan" with the notified body. This should allow the manufacturer to implement changes in accordance with the plan without prior notification to the notified body. The changes concern Annex VII of the MDR/IVDR.

• Repackaging and relabelling (parallel distribution)

Both the prior notification requirement and the obligation to submit a certificate from a notified body under Article 16 MDR/IVDR shall no longer apply.

III. Innovation and availability of medical devices 

• In-house devices

The conditions for the manufacture and use of in-house devices in health institutions are made more flexible. For example, their transfer to other health institutions will be permitted if this is in the interests of patient safety or public health. Under the IVDR, the condition that there is no equivalent device on the market is to be removed. In addition, central laboratories that manufacture and use tests exclusively for clinical trials will be added to the scope of the exemption for in-house devices. The proposed amendments concern Article 5(5) MDR/IVDR.

• Conformity assessment for breakthrough devices (BtX) and orphan devices

Criteria will be introduced which, if met, will allow devices to be classified as breakthrough devices or orphan devices. In addition, breakthrough devices and orphan devices will be subject to a priority and rolling review following classification by an expert panel. Manufacturers will have access to the advice of the expert panel. A new Article 52a MDR and Article 48a IVDR will be inserted for this purpose.

• Grandfathering of legacy orphan devices

Orphan devices that were CE marked under the former Directives and for which an expert panel has confirmed that they meet the criteria of orphan devices enjoy grandfathering. Under certain conditions, they may continue to be placed on the market beyond the transitional periods. This concerns Article 120 MDR and Article 110 IVDR.

• Regulatory sandboxes

Member States and the Commission are given the option of establishing so-called "regulatory sandboxes" in order to meet the requirements of new technologies. This is intended to facilitate both the development and testing of these technologies. The newly inserted Article 1(74) MDR defines a "regulatory sandbox" as a controlled environment which offers manufacturers or prospective manufacturers the possibility to develop, test, validate and use, where appropriate in real-world conditions, an innovative product or technology pursuant to a “sandbox plan” for a limited time under regulatory supervision. For this purpose, Articles 59b and 59c are inserted into the MDR and Articles 54b and 54c into the IVDR. 

• Combined studies involving medicinal products, medical devices and/or in vitro diagnostic medical devices

In order to reduce the administrative burden on sponsors, they will be allowed to submit a single application for combined studies involving medicinal products, medical devices and/or in vitro diagnostic medical devices. This application will trigger a coordinated assessment in accordance with Regulation (EU) No 536/2014 on clinical trials. This Regulation is to be amended accordingly by Article 14a of the Commission's proposal for a European Biotech Act of 16 December 2025. According to the Commission's proposal, a new Article 79a MDR and Article 75a IVDR will be inserted for this purpose.

• Reprocessing of single-use devices

Manufacturers will be obliged to provide a justification for a "single use" claim in the technical documentation in accordance with Annex II of the MDR. Further manufacturers will be required to provide information on appropriate reprocessing as part of the instructions for use in accordance with Annex I 23.4. of the MDR for devices that are not intended for single use. As before, a person who reprocesses a single-use product in the sense of a complete reconstruction shall also be considered the manufacturer of this reprocessed product according to the Commission’s proposal (Article 2(31) MDR). The proposed amendments concern Article 17 MDR. 

IV. Predictability and efficiency

• Conformity assessment

The plan is to streamline the conformity assessment procedure by reducing the involvement of notified bodies in the conformity assessment of low- and medium-risk products (class IIa and IIb as well as class B and C). In addition, no systematic assessment of the technical documentation of representative devices will be required during surveillance activities. No involvement of notified body will be required for class A sterile IVD. Furthermore, notified bodies will be given the possibility to replace on-site audits by remote audits. Surveillance audits will no longer have to be conducted at least every 12 months, but only every 24 months if there are no safety issues. Finally, unannounced audits should only be carried out for valid reasons. This affects MDR: Article 52 and Annexes IX, X, XI and IVDR: Article 48 and Annexes IX, X, XI. 

• Consultation procedure concerning clinical evaluation and performance evaluation

The scope of the consultation procedure regarding clinical evaluation under Article 54 MDR is limited to class III implantable devices. A reverse exception is provided for custom-made devices. In addition, the Commission is authorised to add other types of devices by means of delegated acts. The consultation procedure concerning performance evaluation will be removed. Instead, the possibility of early advice from expert panels for class C and D IVDs is introduced. This concerns IVDR: Article 48 and the newly inserted Article 56a.

• Fee reductions 

In terms of cost efficiency, the Commission’s proposal provides for an amendment to Article 50 MDR. Regarding the fees charged by notified bodies, fee reductions for micro and small manufacturers and for manufacturers of orphan devices are now stipulated directly in Article 50 MDR. In addition, the Commission, in consultation with the Medical Device Coordination Group (MDCG), shall be empowered to adopt implementing acts to set the structure and level of the notified body fees. Furthermore, in the interests of public health or patient health, it shall be possible for the competent authority to impose a contractual obligation on notified bodies.

V. Coordination

• Regulatory status of products and classification

To ensure uniform treatment under EU law, coordination among the competent authorities regarding the qualification of a product and the classification of a device ("Helsinki procedure") will be codified. The intended amendments concern MDR: Articles 4, 4a (new), 51a (new) and 51b (new) and IVDR: Articles 3, 3a (new), 47a (new) and 47b (new).  

• Dispute resolution mechanism 

A dispute resolution mechanism is to be introduced for disputes between manufacturers and notified bodies. This mechanism provides that the authority responsible for notified bodies will act as an "ombudsperson" in case of disputes between manufacturers and notified bodies. It shall be possible for both the manufacturer and the notified body to raise disputes to this ombudsperson. The intended amendment is to be incorporated into the MDR via a new Article 35(6a). Article 31 IVDR will refer to this.

• Enhanced role of external expertise

The role of expert panels and their composition will be broadened. For example, expert panels will be involved in determining the regulatory status of products and classification of devices. They will also provide scientific, technical, clinical and regulatory advice to the Commission, Member States, the Medical Device Coordination Group (MDCG), notified bodies and in certain cases to manufacturers. The tasks previously laid down in Article 106 MDR for expert panels and expert laboratories are further clarified by the addition of a separate Article 106a MDR for expert laboratories. For the IVDR, the proposed amendments concern Article 100.

• Support from the EMA 

The EMA will have a supporting role in various areas, as stipulated in a new Article 106b MDR. On behalf of the Commission, the EMA shall provide scientific, technical and administrative support for the coordination among national competent authorities in several areas in order to facilitate the exchange of experience, cooperation and coordination and to ensure the uniform application of the MDR. It shall also provide scientific, technical and administrative support to the Commission for the establishment of Union regulatory sandboxes. In addition, the EMA shall set up a support scheme for SME manufacturing medical devices and in vitro diagnostic medical devices.

VI. Digitalisation and AI

• Digitisation of compliance tools

Firstly, it should be possible to provide the EU declaration of conformity and certain information and instructions for use in digital form. Secondly, the submission of information pursuant to MDR/IVDR shall be performed electronically. In addition, economic operators will be required to provide their digital contact details in Eudamed. These changes affect MDR: Article 19, Article 110a (new), Annexes I and IV, and IVDR: Article 17, Article 103a (new), Annexes I and IV.

• AI Regulation (EU) 2024/1689 (AI Act)

In order to avoid overlaps and duplicate regulations between the MDR/IVDR and the AI Act, the latter is to be amended in its Annex I so that the MDR and IVDR are moved from Section A to Section B. This is to ensure that, as a rule, only the MDR applies to medical devices and only the IVDR applies to in vitro diagnostic medical devices.

C. Critical discussion and outlook

The Commission's proposal is to be welcomed overall, given its objectives of streamlining the existing legal framework and making it more future-proof and cost-efficient, particularly in view of the difficulties that have come to light in the implementation of the MDR and the IVDR. The adjustments proposed by the Commission also appear to be well chosen. However, not all changes proposed by the Commission deserve approval, and some require further consideration:

• Requirements for the PRRC

The removal of detailed qualification requirements for the PRRC only leads to simplifications in practice when viewed superficially. It goes without saying that the PRRC must have fundamental expertise in the field of medical devices in order to perform the tasks assigned to them. If the previous list of requirements is removed, the question arises as to how the competent authorities are to carry out their checks in practice. If the authorities are not provided with any assessment criteria, it stands to reason that the requirements that have been applied to date will be used as a standard, even if they are no longer enshrined in the text of the regulation. Insofar as mere availability is now sufficient for external PRRCs instead of having the PRRC “permanently and continuously” available, the question of the availability profile arises with regard to the PRRC's responsibility for post-market surveillance. 

• Unlimited validity of certificates of conformity and reduced involvement of notified bodies

The changes associated with the planned removal of the maximum validity period of certificates of conformity suggest that notified bodies will be required to increase their surveillance activities and periodic review of certified devices, depending on the risk class. In contrast, the Commission's proposal stipulates in Annex IX 3.3. that regular surveillance audits and assessments no longer have to be carried out annually, but only every two years. This shall apply in any case if this interval appears justified in view of the results of previous surveillance audits and assessments and if there are no other concerns arising from post-market surveillance and vigilance. Further audits should be able to be carried out as remote audits for justified reasons. Unannounced audits, on the other hand, should only be carried out for valid reasons, Annex IX 3.4. In this respect, the question arises as to whether the fundamental reduction in periodic audits, the admissibility of remote audits and the restriction of unannounced audits can be interpreted as a reduction in the liability standard of notified bodies. Furthermore, it is questionable to what extent the aforementioned reduction in the surveillance standard can be reconciled with the obligation for notified bodies to carry out appropriate surveillance activities, including periodic and risk-adequate reviews, which accompanies the unlimited validity of certificates.

• Amendment to the classification rules

The amendment to classification rule 11 provided for in the Commission’s proposal is editorially unsuccessful. Firstly, it stipulates that DSS should generally be classified as class I. It then provides for exceptions in which DSS is classified in a higher risk class. The third indent provides for classification as class IIa in cases where the output of the DSS is intended for a disease or condition in a non-serious situation. This appears to contradict the basic rule of classifying the DSS as class I. Since it cannot be assumed that the Commission intended to completely undermine the basic rule laid down in its proposal with this exception, it is likely that this is an editorial error. 

• Clinical evidence/use of existing evidence

The simplification provided for manufacturers who wish to refer to the clinical evidence of a product from another manufacturer already on the market inevitably raises the question of how the necessary evidence can be provided without the consent of the manufacturer of the reference product. This question is all the more pressing in view of the notified body's obligation to treat the documents submitted to it as confidential. Since the MDR does not assume that notified bodies perform a sovereign function, it is incompatible with the concept of "generic product assessment". If the regulator nevertheless wishes to grant manufacturers a right of reference – without the consent of the manufacturer of the reference product – the question of protection periods in favour of the manufacturer of the reference product arises as well. Such periods have already been deemed necessary for constitutional reasons in the case of generic product authorisation for medicinal products.

• Reprocessing of single-use devices 

The Commission’s proposal is based on a change of concept with regard to the reprocessing of single-use devices. Whereas the question of the permissibility of reprocessing has so far been determined by the intended purpose of the device and national law, the Commission’s proposal would require manufacturers to justify a “single use” claim. In addition, manufacturers would be required to provide information on appropriate reprocessing as part of the instructions for use in accordance with Annex I 23.4 of the MDR for devices that are not intended for single use. This places the liability risk of incorrect instructions on manufacturers who do not want their products to be reprocessed. In fact, however, the sole responsibility for proper reprocessing should lie with the reprocessor alone.

• Fee reductions 

The Commission's planned powers to intervene in the remuneration structure of notified bodies and the possibility of imposing an obligation to contract constitute serious interference with the contractual freedom of notified bodies operating under private law. On the one hand, they appear to be questionable under both EU and constitutional law and, on the other hand, they lose sight of the concept of notified bodies operating under private law.

• Dispute resolution mechanism

The dispute resolution mechanism provided for in the newly inserted Article 35(6a) MDR is not well thought out. According to this new provision disputes may be raised to the ombudsperson "without prejudice", i.e. without prejudice to other administrative or judicial remedies. This means that decisions taken by the ombudsperson would apparently not be legally binding. If they were, they would have to be subject to legal remedy. The ombudsperson would thus only become an intermediate instance. There is no discernible added value to be gained from the proposed dispute resolution procedure. 

• Support from the EMA

Whether the planned involvement of the EMA is sensible will have to be proven in practice. The EMA will only be able to contribute to better technical coordination among authorities and experts, better coordination and, where necessary, give technical advice to manufacturers in the preparation of clinical trials and assessments if the necessary technical expertise is built up. Given the variety of medical devices and the diversity of the technological environment, this is no small task. On the other hand, the further involvement of an authority, even if only in an advisory capacity, always carries the risk of more complicated and lengthy work processes. It will therefore be necessary to clarify in advance in which areas the involvement of the EMA's expertise can create added value.

Since 7 January 2026, the Commission has been gathering feedback on its proposed amending Regulation. This feedback period, which was originally scheduled to last eight weeks, is currently being extended by one day for each day that the Commission's proposal is not available in all official languages of the EU. Under the ordinary legislative procedure, the first reading is not expected to take place until the end of the first half of 2026 at the earliest. The final version of the amending Regulation is not expected to be adopted before the second quarter of 2027 at this stage. It is to be expected that the current Commission’s proposal will undergo fundamental changes in the ongoing process.