EU MDR 2028: The Portfolio Decisions That Matter Now

For MedTech manufacturers operating in Europe, the 2027 and 2028 transition deadlines are becoming a critical point in portfolio planning.

For Class III and certain Class IIb implantable devices, the transition ends on 31 December 2027. Other Class IIb, Class IIa and certain Class I devices have until 31 December 2028.

These deadlines were established in 2023 under Regulation (EU) 2023/607, giving manufacturers and notified bodies additional time to complete the move from the legacy framework. The extensions were conditional: manufacturers had to lodge an MDR conformity assessment application and have an MDR-compliant quality management system in place by 26 May 2024, followed by a signed agreement with a notified body by 26 September 2024.

The question now is how manufacturers use the additional transition period. For some products, continued investment in certification may be justified. For others, the economics may point towards a different portfolio decision.

The European Commission’s December 2025 proposal is another factor in those decisions. It proposes targeted revisions to the MDR and IVDR covering areas including software classification, certificate validity and notified-body processes.

The transition deadlines remain part of the current regulatory framework, while the proposed reforms are still subject to the legislative process and do not change those deadlines. Manufacturers therefore need to plan against the requirements in force today while considering how potential reforms could affect decisions further ahead.

More Time, Harder Portfolio Choices

MDR compliance requires substantial regulatory and operational investment. Moving a legacy device into the new framework can require updated or additional clinical evidence, quality-system changes, notified-body capacity, and recertification costs that can be significant. Industry cost-mapping studies put the MDR transition at roughly 3.5 to 5% of a manufacturer’s total European revenue, and documented cases show conformity-assessment costs exceeding €800,000 for a single device covering just five years of market access. That burden compounds across larger portfolios. For high-margin lines, that investment can make commercial sense. For low-volume or low-margin SKUs, it may not.

This means assessing each product against revenue contribution, margin, tender performance, market demand, strategic importance, and recertification cost.

Portfolio Rationalisation Could Reshape Tender Supply

Portfolio rationalisation can reshape the competitive landscape.

A device that previously appeared in tenders may no longer be available. A supplier that regularly competed for a contract may exit the category. A hospital or group purchasing organisation may suddenly have fewer viable alternatives.

This makes historical tender performance a less reliable predictor of future revenue. A product may have won repeatedly over the past few years, but if it is no longer available, those historical wins tell commercial teams little about what they can realistically pursue next.

Products that survive portfolio rationalisation may become strategically more important as competitors withdraw comparable devices. A product with modest historical performance could become more valuable if the competitive field around it contracts.

This is why visibility into competitor portfolio decisions matters, including which products are being maintained or discontinued and where portfolio exits could reduce supplier coverage or create gaps in future procurement.

Regulatory Status Is Becoming a Commercial Variable

Treating regulatory information as a separate compliance dataset creates blind spots for commercial teams.

Knowing that a product has strong tender performance does not give teams the full picture. They also need to know whether the product is currently certified, whether its transition is underway, when certification is expected, whether it can be supplied in a target market, and whether it is scheduled to remain in the portfolio.

This information belongs alongside tender intelligence, pricing, customer demand, and competitive data. With the first four EUDAMED modules becoming mandatory on 28 May 2026, regulatory information is also becoming more structured across the device lifecycle. Without it, commercial teams risk pursuing products that may not be available when an opportunity reaches award.

Regulatory intelligence is now core to opportunity qualification, forecasting, and bid strategy, alongside the supplier and product intelligence already used in procurement assessments.

The December 2025 Reform Could Change the Regulatory Economics

The 2027 and 2028 transition deadlines sit alongside the European Commission’s December 2025 proposal to revise the MDR and IVDR.

The Commission proposal aims to simplify rules while maintaining high patient safety standards. It covers software classification, certificate validity, notified-body processes, support for smaller manufacturers, and new pathways for specialised devices. The Commission estimates that the proposed measures could generate more than €3 billion in annual savings.

It would also remove the current five-year cap on certificate validity in favour of risk-based periodic reviews, introduce fee reductions of at least 25% for small enterprises and 50% for micro-enterprises, and create new pathways for breakthrough, orphan and niche devices.

The proposal remains subject to the EU legislative process. Final provisions may still shift as the text moves through Parliament and Council. Rapporteur Oliver Schenk’s draft report was presented to the Public Health Committee in July 2026. A committee vote is scheduled for 3 December 2026, with the Parliament position expected in early 2027. The Irish Council Presidency is also targeting a General Approach by the end of 2026.

For manufacturers making portfolio decisions now, that timing creates a practical constraint. Reforms arriving in 2027 could come too late to change the products already being triaged against the 2027 deadline, leaving only a limited window before the 2028 transition ends.

The risk lies in using potential future changes to justify delaying decisions that are already required under the current framework.

Rule 11 Could Change the Economics of MedTech Software

A potentially significant commercial change involves the proposed revision of Rule 11, which governs software classification under the MDR.

Under the current rules, software that provides information used for diagnostic or therapeutic decisions can fall into Class IIa, IIb or III depending on the seriousness of the potential impact, while other software is classified as Class I. The proposed approach would make Class I the starting point, with software moving into higher classifications depending on the clinical situation and how the output is used for clinical management.

If adopted in its proposed form, this could lower regulatory burdens for some software businesses. The resulting classification could enable a simpler conformity assessment pathway, reduce regulatory costs, and accelerate market access.

This could also reshape the software market. Software companies facing more demanding regulatory requirements could find it easier to bring products to market, while established MedTech manufacturers could face new competitive pressure from specialised software players.

For companies operating in digital health and SaMD, the focus should be on modelling how different regulatory scenarios could affect product economics, launch timing, and portfolio strategy.

IVDR Creates a Separate Regulatory Clock

In vitro diagnostics operate under a separate transition schedule, so a single MDR timeline cannot be applied across an entire mixed portfolio.

For eligible IVDs, the transition periods extend to:

1. 31 December 2027 for Class D devices
2. 31 December 2028 for Class C devices
3. 31 December 2029 for Class B and Class A sterile devices

These dates create distinct milestones across diagnostics portfolios, with different classifications, certification requirements, transition dates, and commercial implications. For organisations operating across medical devices and diagnostics, those differences need to be factored into product, market, and procurement planning.

What MedTech Leaders Should Do Before 2028

Manufacturers should use the transition period to decide what their portfolios should look like by 2028.

That means answering four questions:

1. Which products justify continued regulatory investment?
2. Which products are most commercially important across tenders and markets?
3. Where could portfolio rationalisation create future supply gaps or competitive opportunities?
4. Which parts of the proposed MDR and IVDR reforms could change those decisions?

Answering these questions requires more than regulatory review. Teams need a connected view of products, regulatory status, tenders, and markets to understand how one decision affects the others.

The Decisions Start Now: Connecting Regulatory and Commercial Intelligence

This is the gap Vamstar’s Polaris platform is built to close. Polaris brings regulatory status, product data, tender history and competitive signals into a single view of the market. Tender AI, built on Polaris, applies that view across the tender lifecycle: discovery, qualification, product matching, response and evaluation.

For MedTech manufacturers navigating the MDR transition, that means regulatory status sits alongside tender and competitive intelligence in one place, so commercial teams can see which products to protect, where portfolio changes open up opportunities, and how those decisions carry through to tender strategy.

The MDR transition is already changing the economics of MedTech portfolios. As manufacturers prioritise products for recertification, competitors withdraw selected devices, and regulatory reforms reshape the cost and complexity of compliance, portfolio value will increasingly depend on more than historical revenue or tender performance. The manufacturers best positioned for 2028 will be those that can see how regulatory status, portfolio choices, and market demand are changing together.

Sources: European Parliament and Council, “Regulation (EU) 2023/607” (15 March 2023); European Commission, “Transitional provisions” for medical devices and in vitro diagnostic medical devices; European Commission, “Proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746” (16 December 2025); European Commission, “Staff Working Document on cost savings for the proposal to reduce and simplify regulations on medical and diagnostic devices” (16 December 2025); European Parliament, Legislative Observatory, procedure 2025/0404(COD); European Commission, “EUDAMED Overview”; Fresenius Medical Care Deutschland GmbH, “Financial Impact of EU MDR Compliance: A Cost-Mapping Assessment for Manufacturers,” ISPOR Europe 2025; CORE-MD, cost data on conformity assessment for paediatric and rare-disease devices; Vamstar Polaris OS; Vamstar Tender AI.