CE Mark is getting more complex and more expensive because the Medical Devices Regulation raised evidence and conformity assessment requirements across the board while the supply of notified bodies able to perform those assessments stayed small — only 51 are designated under the MDR and 19 under the IVDR [1]. The European Commission's own targeted evaluation concluded that the benefits of the Regulations came at high and often disproportionate compliance costs, caused also by high regulatory complexity, and that several requirements are disproportionate to the actual risks devices pose [1]. Complexity is still increasing in the near term: EUDAMED became mandatory on 28 May 2026 [5], legacy device registration follows within 12 months, and transition deadlines land in December 2027 and 2028 [1]. The Commission has proposed reforms it estimates could save more than €3 billion per year [1], but they are not law.

The EU's own diagnosis

The most useful document on MDR costs is not a consultancy report. It is COM(2025) 1023 final, the Commission's own legislative proposal of 16 December 2025 [1]. It is unusually candid.

The targeted evaluation behind it found that the benefits of the Regulations for patients are materialising through stronger device safety and greater transparency — but that these achievements come at high and often disproportionate compliance costs, caused also by high regulatory complexity [1].

The Commission's summary of what is wrong lists seven findings. Four of them are cost drivers you will recognise [1]:

  • Certain requirements, especially around conformity assessment, are overly complex, burdensome, lengthy and costly
  • The application of legal requirements by national authorities and notified bodies is not sufficiently aligned
  • Coordination mechanisms are not sufficiently efficient or effective
  • The Regulations have unintended negative impacts on innovation, competitiveness and patient care

It goes further. The proposal states plainly that several requirements are disproportionate to the actual risks posed by the devices, which results in unnecessarily high costs and burdens, and that overly onerous requirements may prompt manufacturers — especially SMEs — to discontinue supplying devices or delay their launch [1].

That is the regulator describing its own framework. Nothing a vendor writes on this subject carries the same weight.

Where the money actually goes

Four structural drivers, all visible in the Commission's analysis.

Notified body scarcity. Under the MDR, most devices need a notified body before a CE mark can be affixed. When the Regulations took effect the number of designated bodies was very low, creating bottlenecks in mandatory pre-market certification [1]. To date 51 notified bodies are designated under the MDR and 19 under the IVDR [1]. A constrained supply of mandatory gatekeepers produces exactly what you would expect: long queues and strong pricing power.

Requirements that scale badly for small manufacturers. SMEs make up around 90% of Europe's medical technology industry, most of them small and micro companies employing fewer than 50 people [1]. In the Commission's call for evidence, a large majority of contributing companies were SMEs, and feedback emphasised that compliance costs are viewed as particularly disproportionate for them [1]. Fixed compliance costs spread over small revenue bases are the whole problem.

Recertification with no risk-based logic. Certificates currently carry a maximum five-year validity, after which notified bodies assess whether they can be renewed. The Commission describes this as creating administrative burden, uncertainty and unnecessary costs [1].

Duplication. The evaluation found unanticipated administrative burden originating from redundant reporting and unnecessary duplication of work [1]. Separate reports covering overlapping ground, validated separately, updated on fixed schedules regardless of risk.

Why it is still getting harder right now

This is the part that makes "the EU is simplifying" a misleading headline for 2026. Three obligations are landing while the reform is still a proposal.

EUDAMED became mandatory on 28 May 2026. Commission Decision (EU) 2025/2371, published 27 November 2025, confirmed four modules as functional and triggered a six-month transition [5]. Actor registration, UDI/device registration, Notified Bodies and Certificates, and Market Surveillance are now compulsory. Without a valid Single Registration Number you cannot legally place devices on the EU market, and non-EU manufacturers register through their EU Authorised Representative.

Legacy device registration follows in November 2026. Devices already on the market before 28 May 2026 must be registered within 12 months of the Official Journal notice.

The transition cliff is real and close. MDR transitional periods extended by Regulation (EU) 2023/607 end on either 31 December 2027 or 31 December 2028 depending on risk class and subject to conditions [1]. IVDR periods run to 2027, 2028 or 2029 [1]. The Commission is explicit that repeated extensions were only a short-term fix that did not address underlying structural problems [1].

So the near-term direction of travel is more work, not less. Anyone telling you MDR is getting easier in 2026 is describing a proposal, not your compliance calendar.

What the December 2025 proposal would actually change

Substantial, and worth knowing even though none of it is law yet. The measures most relevant to cost [1]:

Change What it would mean
Certificate validity The five-year maximum is removed; notified bodies conduct risk-proportionate periodic reviews instead of recertifying
Notified body involvement Reduced for class IIa and non-implantable IIb devices — technical documentation assessment of one representative device per generic device group or category
Class A sterile IVDs Notified body involvement removed entirely
Audits Remote audits permitted; surveillance audits every two years where justified; unannounced audits become for-cause
Notified body fees Mandatory reductions for micro and small manufacturers and for orphan devices; Commission empowered to set fee levels and structure
PRRC Detailed qualification requirements removed; SMEs using an external PRRC need them available, not permanently and continuously available
Clinical data Definition broadened to include studies published in scientific literature that are not necessarily peer-reviewed; equivalence conditions relaxed and the contract requirement with the equivalent device's manufacturer removed
Classification Lower risk classes for certain devices including reusable surgical instruments, accessories to active implantables, and software
PSUR Update frequency reduced by risk class
Vigilance 30 days instead of 15 to report serious incidents not involving death, serious deterioration or public health threats
Well-established technologies New defined category subject to more proportionate requirements
Breakthrough and orphan devices New criteria, with priority and rolling review after expert panel designation

There is also a new international cooperation section — proposed Articles 108a and 108b — under which the Commission and Member States should actively participate in and make use of international regulatory cooperation and reliance mechanisms, naming IMDRF and MDSAP 1]. That runs in the same direction as [WHO's transitional Listed Authority framework, and it is quietly one of the more consequential items for manufacturers holding approvals in more than one jurisdiction.

Read the €3 billion figure carefully

Trade coverage has widely reported savings of €3.3 billion per year. The Commission's own text says something more measured: the combined quantifiable impact of the simplification measures, taking into account the limitations and assumptions outlined, is estimated to reach more than €3 billion per year [1].

Three qualifications matter, and all three come from the proposal itself.

No impact assessment was carried out. The Commission states that an impact assessment was not deemed necessary nor appropriate, in terms of timing and efficiency [1]. The savings estimate instead sits in an accompanying staff working document. That is a lighter evidentiary basis than a full impact assessment, by the Commission's own description.

The figure is EU-wide and industry-wide. It is spread across more than 38,000 medical technology companies in a market worth roughly €170 billion in 2024 [1]. It is not a per-manufacturer saving and should not be read as one.

It assumes the proposal survives contact with the legislature. It will not survive unchanged.

The timeline, realistically

The proposal follows the ordinary legislative procedure, requiring agreement between the European Parliament and the Council. Analysis from law firm Taylor Wessing puts first reading no earlier than the end of the first half of 2026, with the final amending Regulation not expected before the second quarter of 2027, and notes that the Commission's proposal is expected to undergo fundamental changes during the process [3].

Then add implementation. The proposal itself states that the application of certain provisions should be deferred so affected parties have time to comply [1].

The practical read: if you are planning a CE marking project starting now, plan against the current rules. Any relief is a bonus, not a budget line. And if you are tempted to wait for cheaper rules, note that the transition deadlines in December 2027 and 2028 arrive around the same time the reform might — which is a poor combination to bet on.

What this means for your market strategy

Three honest positions, depending on where you sit.

If Europe is your primary market, waiting is not really an option. The transition deadlines are fixed and the reform is not. Legacy devices need their MDR certificates regardless.

If you are choosing which market to enter first, the calculus has shifted slightly — but not in the direction most vendors will tell you. The EU has formally acknowledged its framework is disproportionate and has proposed fixing it. That is a reason to take Europe more seriously over a five-year horizon, not less. What has not changed is the near-term cost of entry.

If you are export-driven and deciding where to spend a limited regulatory budget this year, the comparison worth running is total cost and time to first revenue in each market, not headline fees. On the FDA side those fees are published and fixed: in FY2027 a 510(k) is $28,653, or $7,163 with small business status 4]. There is no notified body queue in the US system, though there is a review process with its own timelines. Our [CE Mark and FDA pathway comparison covers the trade-offs, and if you already hold CE Mark, what transfers to a 510(k) is the more useful question than which regime is cheaper in the abstract.

That last comparison is where most teams lose money — not by picking the wrong market, but by scoping the second market as though it were the first, and rebuilding evidence they already hold. Complizen maps an existing technical file against US requirements so the reusable parts are identified before testing budgets are committed, with regulatory experts who have direct FDA submission experience reviewing the analysis.

Common misreadings

"MDR is being simplified, so costs are coming down." A proposal is not a regulation. Current rules remain fully in force and the amending Regulation is not expected before 2027 [3].

"The EU will save manufacturers €3.3 billion." The Commission's own estimate is more than €3 billion per year across the whole EU industry, produced without a formal impact assessment [1].

"Certificates will no longer expire." The proposal removes the fixed five-year maximum and replaces recertification with risk-proportionate periodic review [1]. Oversight continues; its shape changes.

"Notified bodies are being cut out." Their involvement is reduced for lower and medium-risk devices and removed for class A sterile IVDs [1]. Higher-risk devices still require full assessment.

"The reform will land before the transition deadlines." Nobody knows. Adoption is not expected before Q2 2027 [3]; MDR transition periods end 31 December 2027 and 31 December 2028 [1].

Frequently asked questions

Why is CE Mark getting more complex and more expensive? Because the MDR raised conformity assessment and clinical evidence requirements while the supply of notified bodies stayed small — 51 designated under the MDR, 19 under the IVDR [1]. The European Commission's own evaluation found the framework produces high and often disproportionate compliance costs driven by regulatory complexity, with several requirements disproportionate to the actual risks devices pose [1]. Fixed compliance costs also fall hardest on SMEs, which make up around 90% of the European industry [1].

Is EU MDR getting cheaper? Not yet. The Commission proposed simplification measures on 16 December 2025 that it estimates could save more than €3 billion per year across the industry [1], but the proposal must pass the European Parliament and Council. Adoption is not expected before the second quarter of 2027 [3]. Current MDR and IVDR rules remain fully in force.

What is COM(2025) 1023? The European Commission's legislative proposal of 16 December 2025 to amend the MDR and IVDR, aimed at simplifying rules, reducing administrative burden and improving the predictability and cost-efficiency of notified body certification [1]. It is the most significant proposed revision since the MDR replaced the old directives.

When do the MDR transition periods end? As extended by Regulation (EU) 2023/607, MDR transitional periods end on either 31 December 2027 or 31 December 2028 depending on the device's risk class and subject to certain conditions [1]. IVDR periods end on 31 December 2027, 2028 or 2029 [1].

Is EUDAMED mandatory now? Yes. Four modules — Actor registration, UDI/Devices registration, Notified Bodies and Certificates, and Market Surveillance — became mandatory on 28 May 2026, six months after Commission Decision (EU) 2025/2371 was published [5]. Devices already on the market before that date must be registered within 12 months of the notice.

Will notified body fees come down? The proposal would require notified bodies to reduce fees for micro and small manufacturers and for orphan devices, and would empower the Commission to set the level and structure of those fees [1]. None of this is in force yet.

Should I wait for the MDR reform before starting CE marking? For most manufacturers, no. Transition deadlines in December 2027 and 2028 are fixed while the reform timeline is not, and adoption is not expected before Q2 2027 [3]. Waiting risks missing a hard deadline in exchange for uncertain relief.

Does the reform change anything about FDA clearance? No. It amends EU legislation only. It does contain a new international cooperation section promoting reliance mechanisms including IMDRF and MDSAP [1], which over time may make approvals more portable between jurisdictions — but it creates no recognition of FDA decisions in Europe or the reverse.

Is FDA clearance cheaper than CE marking? The comparison is not simple, and anyone giving you a single number is oversimplifying. FDA fees are published and fixed — $28,653 for a 510(k) in FY2027, or $7,163 with small business status, plus annual establishment registration [4]. Notified body fees are commercially negotiated and vary widely. The larger cost in both systems is usually testing and internal time, which depends on your device and existing evidence rather than the jurisdiction.

What is a "well-established technology device"? A new category proposed in COM(2025) 1023 for devices with a simple, common and stable design, no history of safety issues, well-known clinical performance characteristics, and a long history on the EU market [1]. Devices meeting the definition would face more proportionate requirements. It does not exist in current law.

Key takeaways

The Commission has conceded the point. Its own evaluation found the MDR produces high and often disproportionate compliance costs, with requirements disproportionate to actual device risk [1]. That is a stronger statement than anything in industry commentary.

Scarcity is the structural driver. 51 notified bodies under the MDR and 19 under the IVDR, in a market of more than 38,000 companies that are around 90% SMEs [1].

Burden is still rising in the near term. EUDAMED became mandatory on 28 May 2026 [5], legacy registration follows within 12 months, and transition deadlines land in December 2027 and 2028 [1].

The savings figure is softer than reported. The Commission says more than €3 billion per year, EU-wide, estimated without a formal impact assessment [1] — not the €3.3 billion widely quoted.

Plan against current rules. Adoption is not expected before Q2 2027 and the text will change in negotiation [3]. Relief is a bonus, not a budget assumption.

If you are deciding where a limited regulatory budget goes this year, the question worth answering first is which evidence you already hold and which markets it travels to. Complizen's regulatory strategy engagement maps your device to a US pathway, product code and predicate shortlist, reviewed by a senior FDA expert. See how the strategy service works →

References

  1. European Commission — Proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746, COM(2025) 1023 final, 16 December 2025. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52025PC1023
  2. European Parliament Think Tank — Medical devices: Simplifying the rules (EU Legislation in Progress). https://epthinktank.eu/2026/03/11/medical-devices-simplifying-the-rules-eu-legislation-in-progress/
  3. Taylor Wessing — Reform of the MDR and IVDR: a critical look at the Commission's proposal of 16 December 2025 (secondary source; legal analysis). https://www.taylorwessing.com/en/insights-and-events/insights/2026/02/reform-der-mdr-und-ivdr
  4. Federal Register — Medical Device User Fee Rates for Fiscal Year 2027. https://www.federalregister.gov/documents/2026/07/30/2026-15335/medical-device-user-fee-rates-for-fiscal-year-2027
  5. European Commission — The EUDAMED four first modules will be mandatory to use as from 28 May 2026. https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en
  6. European Commission — EUDAMED overview. https://health.ec.europa.eu/medical-devices-eudamed/overview_en
  7. EUR-Lex — Regulation (EU) 2017/745 on medical devices (MDR). https://eur-lex.europa.eu/eli/reg/2017/745/oj
  8. EUR-Lex — Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). https://eur-lex.europa.eu/eli/reg/2017/746/oj
  9. EUR-Lex — Regulation (EU) 2023/607 amending transitional provisions. https://eur-lex.europa.eu/eli/reg/2023/607/oj
  10. MedTech Europe — EUDAMED reaches a major milestone: mandatory use of the first four modules begins (secondary source; industry association). https://www.medtecheurope.org/2026/06/04/eudamed-reaches-a-major-milestone-mandatory-use-of-the-first-four-modules-begins/
  11. Morgan Lewis — European Commission Issues Proposal to Simplify Medical Devices Regulations (secondary source; legal analysis). https://www.morganlewis.com/blogs/asprescribed/2025/12/european-commission-issues-proposal-to-simplify-medical-devices-regulations
  12. FDA — Medical Device Single Audit Program (MDSAP). https://www.fda.gov/medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap