--- title: MDR Regulatory Updates 2026: What Changed and What It Means description: What changed in the MDR landscape at the turn of 2026: MDCG 2025-10 on PMS, ISO 10993-1:2025, the ISO 14155 amendment, and what they mean for startups. authors: Tibor Zechmeister, Felix Lenhard category: MDR Fundamentals & Regulatory Strategy primary_keyword: MDR updates 2026 canonical_url: https://zechmeister-solutions.com/en/blog/mdr-regulatory-updates-2026 source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # MDR Regulatory Updates 2026: What Changed and What It Means *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* > **At the turn of 2026, the six regulatory items a MedTech startup actually needs to integrate are MDCG 2025-10 on post-market surveillance (December 2025), MDCG 2019-11 Rev.1 on software qualification (June 2025), MDCG 2023-3 Rev.2 on vigilance terms (January 2025), the new EN ISO 10993-1:2025 biocompatibility edition, EN ISO 14155:2020 + A11:2024 for clinical investigations, and the amendment to Commission Implementing Regulation (EU) 2021/2226 on electronic IFU by (EU) 2025/1234 of 25 June 2025. The core MDR text (Regulation (EU) 2017/745) and the transitional extension (Regulation (EU) 2023/607) have not been superseded.** **By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.** --- ## TL;DR - MDCG 2025-10 (December 2025) is the new authoritative guidance on MDR and IVDR post-market surveillance. Any PMS plan you write in 2026 must reflect it. - MDCG 2019-11 was revised in June 2025 (Rev.1). If you are building medical device software, the software qualification and classification answers you relied on in 2024 may be out of date. - EN ISO 10993-1:2025 replaces the 2020 edition. Biocompatibility work in progress under the old edition needs a gap review. - EN ISO 14155:2020 + A11:2024 (amendment approved 27 November 2024) affects clinical investigation plans that go through NB review in 2025 and 2026. - Commission Implementing Regulation (EU) 2021/2226 on electronic IFU was amended by (EU) 2025/1234 of 25 June 2025. If you ship eIFU, re-check your conditions. - This post is a snapshot. Re-read it quarterly. The MDR itself has not been amended beyond the transitional fix in Regulation (EU) 2023/607. --- ## Why a "what changed" post exists at all Founders tell us the same thing in every first meeting: "We read the MDR. We think we get it. But we cannot tell whether what we read last year is still the current answer." That is a reasonable worry. MDCG guidance gets revised. Harmonised standards get new editions. Implementing regulations get amended. The core MDR text is stable, but the interpretive layer around it moves. This post lists the items that actually landed between early 2025 and early 2026 that a founder reading Subtract to Ship at the start of 2026 needs to integrate. Nothing more, nothing less. If an update is not on this list, assume we have not verified it and do not act on it. **This is a time-sensitive post.** It will be re-reviewed every quarter. The `last_updated` field at the top is the date to trust. --- ## 1. MDCG 2025-10 — Post-market surveillance guidance (December 2025) **What it is.** MDCG 2025-10, "Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices," published in December 2025. It describes the PMS system required by the MDR and IVDR, the PMS plan, and the main PMS activities — data collection, assessment, conclusions — and how PMS interacts with the rest of the QMS. **What it changes.** Before MDCG 2025-10, founders were pulling PMS structure from MDR Article 83, MDR Annex III, the ISO 13485 QMS obligations, and a patchwork of notified body expectations. MDCG 2025-10 is the first horizontal MDCG guidance that explicitly describes how the PMS system, the PMS plan, and the PMS activities hang together and how they map to clinical evaluation, risk management, and vigilance. **What it means for startups.** If you are writing your PMS plan in 2026, use MDCG 2025-10 as the structural reference. Any PMS plan drafted in 2024 or earlier should be checked against it — not rewritten blindly, but checked for gaps, especially around how PMS data feeds clinical evaluation updates and risk file updates. Notified bodies will start citing this document in audits. It is the single most important 2026 addition to a startup's reading list. (MDR Articles 83-86 and Annex III remain the legal basis; MDCG 2025-10 is the authoritative interpretation.) --- ## 2. MDCG 2019-11 Rev.1 — Software qualification and classification (June 2025) **What it is.** The revised version of MDCG 2019-11, "Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 — MDR and Regulation (EU) 2017/746 — IVDR," published in June 2025. **What it changes.** MDCG 2019-11 has been the main reference for whether a piece of software is medical device software (MDSW) and, if so, how Rule 11 applies. Rev.1 updates qualification decision trees, classification examples, and the treatment of modules and changes. If your software classification memo cites MDCG 2019-11 without a revision date, it cites the original October 2019 text and needs to be checked against Rev.1. **What it means for startups.** Any SaMD founder who made a qualification or classification decision in 2023 or 2024 should re-read MDCG 2019-11 Rev.1 and check whether the rationale still holds under the revised examples. This is not a rewrite-everything exercise — the core rules (MDR Annex VIII, especially Rule 11) have not moved. But the interpretation did. Get the current version. (MDCG 2019-11 Rev.1, June 2025.) --- ## 3. MDCG 2023-3 Rev.2 — Vigilance terms Q&A (January 2025) **What it is.** The revised version (Rev.2) of MDCG 2023-3, "Questions and Answers on vigilance terms and concepts as outlined in Regulation (EU) 2017/745 and Regulation (EU) 2017/746," published in January 2025. First publication February 2023. **What it changes.** Rev.2 updates the Q&A set covering the distinction between incidents and serious incidents, reporting criteria, malfunctions, user or use errors, indirect harm, reporting timelines, manufacturer awareness dates, field safety corrective actions, periodic summary reports, and Eudamed reporting. **What it means for startups.** Vigilance decision-making — whether an event is an incident, a serious incident, or neither — is where founders get confused fastest and where wrong calls have the highest consequences. If your vigilance SOP references MDCG 2023-3 without a revision number, you are referencing the February 2023 text. Pull the January 2025 Rev.2 and update the SOP. (MDR Articles 87-92 are unchanged; the guidance layer is what moved.) --- ## 4. EN ISO 10993-1:2025 — Biocompatibility (December 2025) **What it is.** The new edition of EN ISO 10993-1, "Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process." ISO 10993-1:2025; the EN version was published in December 2025. It supersedes EN ISO 10993-1:2020. **What it changes.** A new edition of ISO 10993-1 means the framework for biological evaluation within a risk management process has been updated. It covers material characterization, hazard identification, biological endpoint evaluation, and how Part 1 references Parts 2–18 of the series. **What it means for startups.** If your device touches the patient — skin, tissue, blood, mucosa, implant — your biological evaluation plan is built on ISO 10993-1. A biological evaluation report written against the 2020 edition is not automatically invalid, but any new biocompatibility work initiated in 2026 should be planned against ISO 10993-1:2025, and any BER going to notified body review in 2026 needs a gap analysis. Biocompatibility is one of the most expensive parts of technical documentation — get the edition right before you commission testing. (MDR GSPR 10 in Annex I is the legal anchor; EN ISO 10993-1:2025 is the updated harmonised standard.) --- ## 5. EN ISO 14155:2020 + A11:2024 — Clinical investigations **What it is.** EN ISO 14155:2020, "Clinical investigation of medical devices for human subjects — Good clinical practice," with Amendment A11, approved 27 November 2024. **What it changes.** Amendment A11 brings the harmonised Annex Z of the EN version into alignment with the MDR. For startups, the practical consequence is that any clinical investigation plan going through NB or competent authority review in 2025 and 2026 is read against the amended standard, not the 2020 base text alone. **What it means for startups.** If you are running or planning a clinical investigation under MDR Articles 62–82 and Annex XV, your CIP, your investigator brochure, your monitoring plan, and your adverse event reporting workflow should all reference EN ISO 14155:2020 + A11:2024. Re-check any protocol that was locked before the amendment was approved. This is the kind of detail that does not affect whether your investigation is scientifically valid but absolutely affects whether a notified body accepts the paperwork. (MDR Articles 62–82, Annex XV; EN ISO 14155:2020 + A11:2024.) --- ## 6. Commission Implementing Regulation (EU) 2021/2226 as amended by (EU) 2025/1234 **What it is.** Commission Implementing Regulation (EU) 2021/2226 lays down the rules for providing electronic instructions for use (eIFU) under the MDR. It was amended by Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025. **What it changes.** The amendment updates the conditions under which manufacturers may provide instructions for use in electronic form rather than paper. The baseline framework — the definition of eIFU, the concept of professional users, the risk assessment requirement, availability and version management obligations — traces back to MDR Article 2(14) and Annex I, Chapter III, Section 23. **What it means for startups.** If you ship a device with an eIFU, or you are planning to, check your eligibility conditions and your implementation against the consolidated text of (EU) 2021/2226 as amended by (EU) 2025/1234. If you ship paper IFUs, this does not apply to you. eIFU is often an under-estimated area: a notified body will look at your eIFU risk assessment and your website's availability and versioning, and non-conformities there are cheap to prevent and expensive to fix. --- ## What did NOT change (and why that matters) - **The MDR itself.** Regulation (EU) 2017/745 has not been amended beyond Regulation (EU) 2023/607, which extended transitional provisions for legacy devices. If someone tells you the MDR was "rewritten" or "softened" in 2025 or 2026, ask them for the Official Journal reference. There isn't one. - **The transitional deadlines.** The extended transitional provisions from Regulation (EU) 2023/607 remain the governing transitional regime. See post 026 for the full breakdown. - **The classification rules.** MDR Annex VIII rules 1–22 are unchanged. MDCG 2021-24 remains the interpretive guidance, with the Borderline Manual v4 (September 2025) as the case-by-case reference. Stability is a feature. The worst thing a regulatory framework can do to a startup is move unpredictably. The MDR moved violently from 2020 to 2023; in 2025 it mostly didn't. Use that. --- ## The Subtract to Ship angle: what to cut from old plans, what to add **Cut:** Any reference in your QMS procedures to MDCG 2023-3 without the Rev.2 tag. Any reference to MDCG 2019-11 without the Rev.1 tag. Any biocompatibility plan that cites only EN ISO 10993-1:2020. Any clinical investigation plan that cites only EN ISO 14155:2020 without A11:2024. Any eIFU implementation that cites only (EU) 2021/2226 without the 2025/1234 amendment. **Add:** One PMS plan review against MDCG 2025-10. Write the delta in one page. Do not rewrite the plan unless the delta is material. That is the Subtract to Ship move — check, don't rebuild. **Don't touch:** Your MDR article citations. The base text is stable. Rewriting references to MDR articles is wasted effort in 2026. --- ## Reality Check — Where do you stand? 1. Can you name the current revision of every MDCG guidance document your QMS references? If not, you have drift. 2. When was your biological evaluation plan last reviewed against the current edition of ISO 10993-1? If the answer predates December 2025, you have a gap review to run. 3. Does your clinical investigation plan (if you have one) reference EN ISO 14155:2020 + A11:2024 explicitly? If it says only "ISO 14155:2020," update the reference and check the delta. 4. If you ship eIFU, when did you last review your eligibility and implementation against the consolidated text of (EU) 2021/2226? Has anyone on your team even read (EU) 2025/1234? 5. Is your PMS plan written against MDCG 2025-10, or against the MDR Annex III text alone? If the latter, you are not wrong — you are just not current. 6. Do you have a quarterly regulatory watch process, or do you find out about guidance revisions from LinkedIn posts? One of those is a QMS input. The other is a rumour. --- ## Frequently Asked Questions **Was the MDR itself amended in 2025 or 2026?** No. Regulation (EU) 2017/745 has not been amended beyond Regulation (EU) 2023/607, which extended transitional provisions for legacy devices. Guidance documents (MDCG) and harmonised standards have been revised, but the MDR text itself has not. **What is the most important 2026 change for startups to read?** MDCG 2025-10 on post-market surveillance, published December 2025. It is the first horizontal MDCG guidance describing how the PMS system, PMS plan, and PMS activities fit together and map to clinical evaluation, risk management, and vigilance. Every 2026 PMS plan should reference it. **Do I have to rewrite my technical documentation when a standard gets a new edition?** No. You do a gap review. If the delta is immaterial to your device, you document that and move on. If the delta is material, you update the affected sections. The worst move is to rewrite everything; the second worst move is to ignore the new edition. **Where can I check whether an MDCG document has been revised?** The European Commission's MDCG guidance page is the authoritative source. Any document with a "Rev.1" or "Rev.2" in the filename or header has been updated. Always check the revision date on the cover page, not just the filename. **How often should I re-read this post?** Quarterly. Guidance and standards move. The `last_updated` field at the top of this post is the date to trust. If the field is more than a quarter old, the post is due for review. --- ## Related reading - [What is the EU MDR?](what-is-eu-mdr) — the pillar post that defines the baseline this update post sits on top of. - [MDR transition periods explained](mdr-transition-periods) — the framework for understanding what deadlines are actually in force. - [MDR amendment (EU) 2023/607 and extended transition periods](mdr-amendment-2023-607-extended-transition-periods) — the last real MDR text amendment and why it matters. - [Harmonized standards under MDR — complete list 2026](harmonized-standards-under-mdr-complete-list-2026) — the current list of harmonised standards with edition dates. - [MDR regulatory outlook 2027](mdr-regulatory-outlook-2027) — what we expect (and explicitly do not know) about the year ahead. --- ## Sources 1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, consolidated text. EUR-Lex. 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. MDCG 2025-10, "Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices," December 2025. 4. MDCG 2019-11 Rev.1, "Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 — MDR and Regulation (EU) 2017/746 — IVDR," October 2019; Rev.1 June 2025. 5. MDCG 2023-3 Rev.2, "Questions and Answers on vigilance terms and concepts as outlined in Regulation (EU) 2017/745 and Regulation (EU) 2017/746," February 2023; Rev.2 January 2025. 6. EN ISO 10993-1:2025, "Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process." EN published December 2025; supersedes EN ISO 10993-1:2020. 7. EN ISO 14155:2020 + A11:2024, "Clinical investigation of medical devices for human subjects — Good clinical practice." Amendment A11 approved 27 November 2024. 8. Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use of medical devices, as amended by Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025. --- *This post is part of the MDR Fundamentals & Regulatory Strategy series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. This is a time-sensitive post and will be re-reviewed quarterly; check the `last updated` date at the top.* --- *This post is part of the [MDR Fundamentals & Regulatory Strategy](https://zechmeister-solutions.com/en/blog/category/mdr-fundamentals) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*