MDR/IVDR: What’s Changing - and What Transition Periods Apply?

European regulations governing medical devices and in vitro diagnostic medical devices are once again undergoing changes. With its reform proposal from December 2025, the European Commission has an objective to make the MDR and IVDR more practical, efficient, and risk based. At the same time, the existing regulations and transition periods remain unchanged. Manufacturers, importers, and other economic operators must both implement current law and keep an eye on potential changes.

This article provides an overview of the status of the reform initiative, the key proposed changes, and the transitional periods that remain in effect for existing products. This gives companies a basis for their regulatory planning and enables them to distinguish between current obligations and potential future developments.

Status of the MDR/IVDR reform

The Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) entered into force in 2017. However, their respective effective dates were staggered. The MDR has been in effect since May 26, 2021, and the IVDR since May 26, 2022. The previous directives now apply only within the framework of the transitional provisions established for certain existing products.

Both regulations have significantly tightened the requirements for clinical evidence, Conformity assessment, vigilance, Market surveillance, and transparency. The transition to the MDR and IVDR proved particularly challenging in practice. Experts have consistently criticized the stricter and, in some cases, unclear requirements, the limited capacity of Notified Bodies, the lengthy and unpredictable certification processes, and the high administrative burden.

Finally, the European Commission has now presented the current reform proposal. With the proposal “COM (2025) 1023 final” dated December 16, 2025, the Commission has initiated a “targeted revision” of the MDR and IVDR. The proposal follows a multi-year evaluation that the Commission has been conducting since 2024.

The proposal is undergoing the standard legislative procedure. It will be debated in the European Parliament and the Council. During this procedure, amendments to the text are possible and common. As of now, no effective date has been set. Until the proposal is adopted and published in the Official Journal, the MDR and IVDR remain fully applicable in their current versions.

Thus, the reform proposal outlines a direction but does not reflect the current legal situation. Statements regarding individual planned changes are subject to further clarification during the legislative process.

Planned changes

The proposal introduces extensive changes with the objective of overall simplification. An overview of the proposed changes is provided below.

Person Responsible for Regulatory Compliance (PRRC): The qualification requirements for the PRRC are to be simplified. For SMEs in particular, it should be sufficient to have an external PRRC available, rather than requiring one to be permanently and continuously on hand.
Certificate Validity and Recertification: The current maximum certificate validity period of five years is to be eliminated. In the future, Notified Bodies will be able to conduct risk-based periodic reviews during the certificate’s validity period instead of regular recertifications.
Clinical Evidence and Data Basis: Demonstrating safety and performance is to be facilitated through broader recognition of clinical data, more flexible equivalence demonstrations, greater use of non-clinical data, and new methods such as in silico testing.
Well-established technologies: A separate definition is to be introduced for these products so that more proportionate requirements apply and existing device listings can be replaced.
Repackaging and relabeling: For certain repackaging and relabeling activities, the requirement for a certificate from a Notified Body and the prior notification requirement are to be eliminated.
Classification rules: Certain classification rules are to be adjusted so that specific product groups - such as reusable surgical instruments, accessories for active implantable devices, and software - can be assigned to lower risk classes.
SSCP / SSP: The requirement to prepare both summary reports is to be limited to products for which the technical documentation must be reviewed by a Notified Body.
PSUR: The frequency of Periodic Safety Update Reports is to be reduced, with the review to be incorporated into the Notified Body’s regular monitoring activities in the future.
Reporting Deadline for Serious Incidents: For certain serious incidents, the reporting deadline is to be extended from 15 to 30 days.
Post-Certification changes: In the future, Notified Bodies are to clearly specify which changes may be implemented without prior notification, without prior approval, or only after approval.
Certain performance studies: Performance studies involving only routine blood draws will no longer require approval, and the requirement to report certain companion diagnostic studies using residual samples will be eliminated.
Products in health institutions: The conditions for manufacturing and use of such products are to be made more flexible.
Supply Disruptions or Product Discontinuations: A central IT tool linked to EUDAMED will be provided for reporting such issues regarding specific products.
Breakthrough and Orphan Devices: Criteria are to be introduced so that these products can receive prioritized assessment procedures and consultancy following attestation by expert panels.
Exemptions in emergency situations: The Commission and competent authorities should be able to grant exemptions for the placing on the market or for certain requirements for CE-marked products in specific emergency situations.
Regulatory Sandboxes: Member States and the Commission should be able to establish regulatory sandboxes to develop and test innovative medical devices and IVDs under controlled conditions.
Reprocessing of single-use devices: Manufacturers will in the future be required to explicitly justify why a product is determined for single use only, while products not determined as single-use devices may be reprocessed in accordance with the manufacturer’s instructions.
IVD Kits: For IVD kits, it should be clarified which components fall under the definition of a kit as set forth in Article 2(11) of the IVDR.
Grandfathering of legacy orphan devices: Certain orphan products that were already CE-marked under previous legislation will be permitted to continue to be placed on the market under certain conditions even after the transition periods have expired.
Nanomaterials: The outdated MDR definition of nanomaterials is to be deleted and replaced with a reference to the Commission Recommendation of June 10, 2022.
Structured Dialogue: An explicit legal basis is to be established for structured dialogues between Manufacturers and Notified Bodies before and after submission.
Conformity Assessment Procedures: The involvement of Notified Bodies should be reduced for low- and medium-risk classes and made more proportionate to risk.
Clinical Evaluation Consultation Procedure (CECP), Performance Evaluation Consultation Procedure (PECP), and Early Advice: The clinical consultation procedure is to be limited to Class III implantable devices, while the IVDR Performance Evaluation Consultation Procedure is to be replaced by Early Advice for Class C and Class D IVDs.
Notified Body Fees: Fee reductions are to be provided for micro and small manufacturers as well as orphan products, and the Commission is to be able to regulate the amount and structure of the fees.
Regulatory Status and Classification: Coordination among competent authorities regarding product qualification and classification is to be codified and supported by potential expert panel opinions.
Designation and Monitoring of Notified Bodies: The designation and monitoring of Notified Bodies are to be streamlined through Joint Assessment Teams, while the full five-year reassessment is to be eliminated.
Dispute Resolution: The competent authority responsible for Notified Bodies is to assume the role of an ombudsman to resolve disputes between Manufacturers and Notified Bodies during the conformity assessment process.
Coordination of Notified Bodies: The participation of Notified Bodies in the NBCG-Med is to be strengthened, and this coordination group is to report to the MDCG in the future.
Expert Panels and Expert Laboratories: The role, composition, and tasks of the expert panels are to be expanded, while expert laboratories are to be regulated separately, and the EMA is to continue to provide the secretariat.
EMA Support for Competent Authorities: The EMA is to provide scientific, technical, and administrative support to competent authorities on issues such as borderline cases, classification, multinational studies, exemptions, vigilance, and Market surveillance.
Digitization of Compliance Tools: Declarations of Conformity (DoC), certain labeling information, electronic instructions for use, submissions, and digital EUDAMED contacts are to be made more digitally accessible or made mandatory.
Digitization of conformity assessment: Manufacturers should be able to create and submit technical documentation, reports, and other documents digitally as part of the conformity assessment process.
Online sales: For online sales, essential information regarding product identification and access to the instructions for use must be provided.
UDI and EUDAMED: The regulations governing UDI assignment and registration in EUDAMED are to be clarified, and certain electronic systems are to be permitted even outside of EUDAMED.
International Cooperation: A new section is intended to promote international cooperation and reliance mechanisms, particularly with regard to global regulatory convergence, the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Programme (MDSAP).
Combined Studies: For combined studies involving drugs, medical devices, and/or IVDs, a single application with a coordinated review is to be permitted.
Cybersecurity: Cybersecurity is to be explicitly included in the general safety and performance requirements, and relevant vulnerabilities or incidents are to be reported to CSIRTs and ENISA via EUDAMED.
Regulation (EU) 2022/123: The European Medicines Agency (EMA)’s mandate for the secretariat of the Medical Device Expert Panels should be aligned with the amended MDR provisions.
Regulation (EU) 2024/1689: The MDR and IVDR are to be moved from Section A to Section B of Annex I to the AI Act in order to reduce overlaps with medical device and IVD regulations.

In addition to, but separately from, the reform proposal, the Commission has adopted Implementing Regulation (EU) 2026/977, which establishes more uniform requirements for Conformity assessment by Notified Bodies. This Implementing Regulation is in force but generally does not take effect until February 25, 2027. Certain transitional provisions provide for different dates of application.

Applicable transition periods under the MDR (Art. 120)

The transition periods for legacy devices are unaffected by the reform proposal and are set forth in Article 120 of the MDR, as amended by Regulation (EU) 2023/607. Legacy devices are medical devices that were lawfully placed on the market under the MDD 93/42/EEC or AIMDD 90/385/EEC and that meet the requirements of Article 120 of the MDR for eligibility under the transitional provisions. The classification according to Annex VIII of the MDR is decisive for determining the applicable deadlines.

For Class III products and for Class IIb implantable devices, a transition period generally applies until December 31, 2027. However, certain Class IIb implantable devices - in particular sutures, staples, dental fillings, braces, dental crowns, screws, wedges, plates, wires, pins, clips, and fasteners - benefit from the extended transition period until December 31, 2028. The same deadline of December 31, 2028, applies to the remaining Class IIb products, to Class IIa products, Classes Is, Im, and Ir, as well as to so-called “upgraded” Class I products that, under the MDR, require the involvement of a Notified Body for the first time - for example, certain software products or reusable surgical instruments.

A separate transitional provision applies to Class III custom-made implantable devices. Under the conditions set forth in Article 120(3f) of the MDR, these devices could be placed on the market or put into service without an MDR certificate from a Notified Body until May 26, 2026, provided that an application was submitted in a timely manner and a written agreement was concluded with a Notified Body.

The extended transition periods apply only under the conditions set forth in Article 120(3c) of the MDR. In particular, this requires that the product continue to comply with the requirements of the relevant directive, that there be no substantial change in its design or intended purpose, that there be no unacceptable risk to health or safety, that the Manufacturer have established a Quality management system by May 26, 2024, at the latest, and that the Manufacturer have submitted a formal application to a Notified Body by May 26, 2024. In addition, a written agreement between the Manufacturer and the Notified Body must be concluded by September 26, 2024, at the latest.

Even during the transition period, various MDR requirements apply to these products, particularly regarding Market surveillance, vigilance, the registration of Economic operators and products, and regulatory market surveillance. If the requirements are met, the relevant directive certificates generally remain valid until the end of the applicable transition period, unless they are withdrawn.

Applicable transition periods under the IVDR (Art. 110)

For in vitro diagnostic medical devices, the transition periods are set forth in Article 110 of the IVDR, as amended by Regulation (EU) 2024/1860. The applicable transition period depends on the product’s classification under the IVDR. For Class D products, the transition period runs until December 31, 2027, for Class C products, until December 31, 2028, and for Class B products and sterile Class A products, until December 31, 2029.

For IVDs with a certificate issued under the IVDD, the validity of which continues pursuant to Article 110(2) of the IVDR, the transition period generally ends on December 31, 2027.

For IVDs that were not subject to the involvement of a Notified Body under the IVDD but require a Notified Body for the first time under the IVDR, the aforementioned deadlines apply, depending on the future IVDR class, until December 31, 2027 (Class D), December 31, 2028 (Class C), or December 31, 2029 (Class B and Class A - sterile).

The extended transition periods apply only under certain conditions. These include, in particular, that the product continues to comply with the requirements of the IVDD, that there is no substantial change in design or intended purpose, that there is no unacceptable risk to health or safety, and that the Manufacturer has established a Quality management system in accordance with Article 10(8) of the IVDR by May 26, 2025, at the latest.

In addition, different deadlines apply for involving a Notified Body, depending on the product class. For Class D products, the application for Conformity assessment had to be submitted by May 26, 2025, and the written agreement had to be concluded by September 26, 2025. For Class C products, the deadlines are May 26, 2026, and September 26, 2026, respectively; for Class B products and sterile Class A products, the deadlines are May 26, 2027, and September 26, 2027, respectively.

It should also be noted that certain IVDR requirements, in particular those related to market surveillance, vigilance, and the registration of economic operators and products - are already applicable during the transition period.

Since only a limited number of Notified Bodies have been designated under the IVDR so far, and certification procedures often require a significant lead time, it is recommended to submit applications as early as possible.

Elimination of the sell-off date

Regulation (EU) 2023/607 and Regulation (EU) 2024/1860 have eliminated the so-called “sell-off date” for devices covered by the transitional provisions of the MDR and IVDR. This applies to Article 120(4) of the MDR and Article 110(4) of the IVDR.

Consequently, products that have been lawfully placed on the market may continue to be made available on the market or put into service even after the previous sell-off deadline has expired. The only limitation is the shelf life or expiration date of the individual product. For distributors and operators holding inventory, this eliminates the pressure to sell off stock by a fixed deadline.

Conclusion

The transition periods are current law and have fixed deadlines. They determine the latest date by which a product must be MDR- or IVDR-compliant in order to continue to be placed on the market beyond the respective transition period. The reform is a proposal and is still undergoing the regular legislative process. It may bring future simplifications, but as things stand, it does not change the current deadlines.

For planning purposes, it therefore makes sense to base certification on the current deadlines and to monitor the reform. Waiting for potential future simplifications carries the risk that deadlines will expire before the reform takes effect.

If you would like to classify your existing products according to the current deadlines or assess the impact of the planned changes on your strategy, we would be happy to assist you.