In December 2025 the European Commission published a proposal that acknowledges, in writing, that the MDR in its current form created a documentation burden disproportionate to patient safety for low-risk and low-mid-risk devices. The proposal is not law, not a timeline, and not a blanket escape hatch. For founders in 2026, it is a signal about where the regulatory wind is blowing, not a reason to stop building a compliant technical file today.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • The European Commission published a proposal in December 2025 that openly acknowledges MDR overreach for low-risk and low-mid-risk devices.
  • The proposal is a political and legislative signal, not a regulation. Regulation (EU) 2017/745 and Regulation (EU) 2023/607 remain the binding law.
  • Nothing in the proposal yet removes the obligation to hold a compliant QMS, a technical file, and clinical evidence proportionate to the device class.
  • Founders should continue to build for the MDR as written today, while tracking the legislative path of the proposal through the European Parliament and Council.
  • The Subtract to Ship response is to do only what the current MDR actually requires, cut every gold-plated deliverable, and stay ready to benefit if relief arrives.

Why this matters (Hook)

For five years, the dominant emotion around MDR in the European MedTech startup ecosystem has been frustration. Tibor has sat on both sides of the table, as a Notified Body lead auditor and as a founder of four MedTech companies, and has watched the same pattern repeat. A small team with a genuinely useful low-risk device spends eighteen months assembling documentation that, honestly, does not measurably change the safety profile of the product. The founders know it. The auditors know it. The regulators quietly know it too.

In December 2025 that quiet knowledge became public. The European Commission published a proposal, reportedly around 170 pages in length, that effectively admits MDR in its current form was an overkill for the lower-risk end of the classification spectrum. The language in the proposal, according to early summaries circulating in the industry, acknowledges that the extended documentation burden did not always serve patient safety.

Felix has spent the last months watching founder reactions to this news on LinkedIn and in coaching calls. The reactions divide cleanly into two camps. One camp reads the headline and decides the MDR is about to be rolled back, so they can slow down. The other camp ignores the proposal entirely because nothing has changed in the binding text yet. Both reactions are wrong. The correct reading sits between them.

What MDR actually says (Surface)

The binding law in April 2026 is still Regulation (EU) 2017/745, as amended. Nothing in the December 2025 Commission proposal changes that. A founder placing a device on the EU market in 2026 is governed by the same articles they were governed by in 2025.

The core framework has not moved:

  • Article 5 still defines the conditions for placing a device on the market.
  • Article 10 still defines general obligations of manufacturers, including the QMS requirement.
  • Article 51 and Annex VIII still govern classification.
  • Article 52 still defines the conformity assessment procedures by class.
  • Article 61 and Annex XIV still govern clinical evaluation.
  • Articles 83 to 86 still govern post-market surveillance.
  • Articles 87 to 92 still govern vigilance.
  • Article 120, as amended by Regulation (EU) 2023/607, still governs the transitional provisions for legacy devices.

What has changed is that the European Commission, the body that drafts EU legislation, has put in writing that it is willing to reopen parts of this framework. A Commission proposal is the first step in the ordinary legislative procedure. It then goes to the European Parliament and the Council of the EU. Amendments, negotiations, and political compromises follow. A proposal published in December 2025 realistically translates into adopted changes somewhere between 2027 and 2029, with implementation timelines beyond that.

Tibor frames it bluntly: the proposal is a door opening. It is not the founder walking through it.

A worked example (Test)

Consider a three-person startup in Graz developing a Class IIa non-active device for home use. Their technical file is about sixty percent complete. Their QMS to EN ISO 13485:2016+A11:2021 is certified. They have a Notified Body contract and a clinical evaluation plan that relies on a mix of literature, equivalence, and a small post-market clinical follow-up study.

In January 2026 the founder reads a LinkedIn post saying the EC wants to deregulate MDR for low-risk devices. The founder's first instinct is to pause the clinical work, wait for the relief, and save cash.

Tibor's response: do not pause. Here is why.

First, the proposal does not currently mention Class IIa carve-outs at the level of detail required to change a real certification plan. The public commentary talks about the lowest-risk end of the spectrum, meaning Class I and some Class IIa, but the exact cutoffs remain unresolved until the Parliament and Council weigh in.

Second, even in the most optimistic scenario, transitional arrangements for any new framework will mirror the pattern of Regulation (EU) 2023/607, where legacy devices keep their existing obligations during a multi-year runway. A device that is not already on the market cannot benefit from a legacy carveout it does not qualify for.

Third, the founder's NB slot is scarce. Losing a booked slot to wait for a legal change that may take two to four years destroys more value than a revised clinical evaluation plan would save.

The correct move is to finish the file as currently required, secure the CE mark, enter the market, generate real-world data, and re-evaluate documentation obligations when and if the reform is adopted. The startup that ships in 2026 under current MDR will be in a stronger position to benefit from any 2028 relief than the startup that paused.

The Subtract to Ship playbook (Ship)

The Subtract to Ship response to a political signal like the December 2025 proposal is disciplined rather than reactive. Felix has coached 44 startups through MDR, and the founders who handled previous regulatory signals well all did the same five things.

Step 1: treat the proposal as intelligence, not as law. Print it, read the executive summary, mark the sections that could plausibly affect your device class, and file it. Come back to it every quarter. Do not redesign your regulatory plan around a document that has not yet been voted.

Step 2: audit your technical file against actual current MDR requirements, not against industry folklore. Many startup files are bloated not because MDR requires it but because consultants added documents that no article, annex, or MDCG guidance actually mandates. Go line by line. For every document, write the MDR article, annex, or MDCG reference that requires it. Delete any document that has no reference. This is the real subtraction the Commission proposal should inspire, and it is legal today.

Step 3: keep the QMS to EN ISO 13485:2016+A11:2021 tight. Regardless of any future reform, the QMS is the spine of any CE-marked device. A lean, well-run QMS is cheaper to operate than a bloated one, and it survives every legislative cycle.

Step 4: track the legislative path publicly. The Commission proposal will move through the Parliament and the Council. Both bodies publish amendments and rapporteur reports. Subscribe to the MDR working group updates, the MedTech Europe newsletter, and the national competent authority bulletins. Do not rely on LinkedIn summaries.

Step 5: plan two scenarios in parallel. The base case: no reform arrives before your certification. The upside case: reform arrives and you can retire specific documents or skip specific deliverables. Design your regulatory budget around the base case and treat any upside as a refund, not as a plan.

Tibor adds one more rule. The proposal should not change the answer to the founder tell question. A founder who in April 2026 says "we will deal with MDR later, the EC is going to deregulate anyway" is still in trouble. A founder who says "we know this is a medical device, MDR is critical, how do we tackle it step by step, and by the way we are watching the reform path" is going in the right direction.

Reality Check

Answer these honestly before deciding what to change based on the December 2025 proposal.

  1. Do you know whether your device falls into the classes the proposal actually addresses, or are you assuming it does?
  2. Have you read the Commission proposal yourself, or only summaries of it?
  3. Can you cite the MDR article, annex, or MDCG guidance that requires every single document in your current technical file?
  4. Does your certification plan still work if no reform is adopted before 2029?
  5. Is your Notified Body slot booked, and does the NB know your intended class and conformity assessment route?
  6. Is your QMS genuinely lean, or has it absorbed consultant-added processes that no regulation requires?
  7. Are you monitoring the legislative path through the Parliament and Council, or relying on headlines?
  8. If relief arrives in 2028, do you have a documented plan for what you would retire from your technical file?

Frequently Asked Questions

Is MDR being cancelled or replaced? No. Regulation (EU) 2017/745 remains in force. The December 2025 Commission proposal is the first step of a legislative amendment process, not a cancellation. The binding law and the obligations for founders have not changed.

Does the proposal affect legacy devices under Regulation (EU) 2023/607? Not directly. Regulation (EU) 2023/607 extended transitional deadlines for legacy MDD certificates. The December 2025 proposal is a separate track and does not currently alter those transitional provisions.

Should a Class I startup stop preparing a technical file? No. Class I self-certification still requires a technical file, a declaration of conformity, a PRRC where applicable, and registration. None of that has been removed. A founder who stops preparing documentation now will simply be behind when certification time arrives.

Will Notified Bodies become cheaper because of the proposal? Unlikely in the short term. Notified Body pricing reflects auditor time, accreditation costs, and demand. None of those drivers change with a proposal that is still years from adoption.

How should a founder talk about the proposal to investors? Honestly. Describe it as a forward-looking regulatory signal that may reduce compliance costs on a multi-year horizon. Do not describe it as imminent relief. Investors who know MedTech will discount optimistic interpretations heavily.

What is the single most important action to take now? Read the proposal yourself and audit your current technical file against real MDR requirements. Both actions are free, both sharpen your regulatory judgment, and both position the company to benefit from any future relief without betting on it.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. OJ L 117, 5.5.2017. Articles 5, 10, 51, 52, 61, 83–86, 87–92, 120.
  2. Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
  3. European Commission, proposal published December 2025 on MDR framework reform.