In brief

  • From 10 November 2026, nine new or revised harmonised standards confer a presumption of conformity with Regulation (EU) 2017/745 on medical devices. Two replace older versions, EN ISO 11137-1:2026 for radiation sterilization and EN ISO 14155:2026 for clinical investigation, while seven appear on the list for the first time: natural rubber latex male condoms, two parts of the biological evaluation series, one part of the washer-disinfector series, laser equipment, non-laser light source equipment and small-bore connectors for liquids and gases.
  • The old versions do not leave the list straight away. EN ISO 11137-1:2015 and EN ISO 14155:2020, each with its amendment, remain a basis for the presumption until 10 May 2028, that is, for another 547 days. A second decision applies the same rule to the list for in vitro diagnostic medical devices, where only the radiation sterilization standard changes.
  • It affects manufacturers, authorised representatives and importers of medical devices selling in Romania, notified bodies, sterilization facilities and sponsors of clinical investigations. Patients will see no change to the product; what changes is the standard on which the manufacturer bases its declaration of conformity.
Act: Commission Implementing Decision (EU) 2026/2479 of 9 November 2026 amending Implementing Decision (EU) 2021/1182, and Commission Implementing Decision (EU) 2026/2481 of 9 November 2026 amending Implementing Decision (EU) 2021/1195
Published: Official Journal of the European Union, L series, 2026/2479 and 2026/2481 of 10 November 2026
In force from: 10 November 2026, the date of publication; the deletion of the old versions applies from 10 May 2028

From 10 November 2026, a medical device manufactured and tested in accordance with one of the nine standards published by the European Commission is presumed to conform to the requirements of Regulation (EU) 2017/745 that the standard covers. On 9 November 2026 the Commission adopted Implementing Decision (EU) 2026/2479, which adds to the list of harmonised standards for medical devices, and Implementing Decision (EU) 2026/2481, which changes a single entry on the list for in vitro diagnostic medical devices, that is, the reagents, analysers and tests used on samples taken from the human body. Both appeared the next day in the Official Journal of the European Union, L series, one day after contact lenses began to receive a single UDI identifier per design, also under Regulation (EU) 2017/745.

The core of both acts is the presumption of conformity. Recital 1 of each decision refers to Article 8(1) of the regulation it supports: devices that are in conformity with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union, “are to be presumed to be in conformity with the requirements covered by those standards or parts thereof set out in that Regulation”. In short, a manufacturer that follows the published standard no longer has to show that its method is suitable for the requirement in question. The presumption runs from the day the reference is published, which is why both decisions enter into force on 10 November 2026 itself, without the usual twenty-day period.

The list for medical devices, the Annex to Implementing Decision (EU) 2021/1182, receives two superseding references, as new entries inserted between existing ones, and seven new entries, numbered 66 to 72. The official titles, as they appear in the English version of the Official Journal of the European Union:

  • Entry 3a, EN ISO 11137-1:2026, “Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2025)”, which replaces entry 3.
  • Entry 39a, EN ISO 14155:2026, “Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2026)”, which replaces entry 39.
  • Entry 66, EN ISO 4074:2026, “Natural rubber latex male condoms – Requirements and test methods (ISO 4074:2026)”.
  • Entry 67, EN ISO 10993-6:2026, “Biological evaluation of medical devices – Part 6: Tests for local effects after implantation (ISO 10993-6:2026)”.
  • Entry 68, EN ISO 10993-7:2026, “Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2026)”.
  • Entry 69, EN ISO 15883-6:2026, for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment.
  • Entry 70, EN IEC 60601-2-22:2020 with amendment EN IEC 60601-2-22:2020/A11:2026, “Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment”.
  • Entry 71, EN IEC 60601-2-57:2026 with amendment EN IEC 60601-2-57:2026/A11:2026, “Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use”.
  • Entry 72, EN ISO 80369-1:2026, “Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements (ISO 80369-1:2025)”.

The list for in vitro diagnostic medical devices, the Annex to Implementing Decision (EU) 2021/1195, receives a single new entry, 2a, with the same EN ISO 11137-1:2026, which replaces entry 2. EN ISO 14155 does not appear on this list, because performance studies of diagnostic tests have their own standard, EN ISO 20916:2024, which is already listed.

The catch lies in Article 2 of each act. Decision 2026/2479 states that “Points (1) and (3) of the Annex shall apply from 10 May 2028”, and these are precisely the points that delete entries 3 and 39, that is, the old versions of the two superseded standards. Decision 2026/2481 does the same with point (1), the deletion of entry 2, “from 10 May 2028”. Recital 12 of the first decision explains why: manufacturers and other economic operators need time to adapt their processes and devices. Until 10 May 2028, the old and the new version therefore sit side by side on the list, and each confers the presumption of conformity.

What it changes in practice

The first to feel the effect are the facilities that sterilize by irradiation, with gamma rays, electron beams or X-rays, and the manufacturers whose devices pass through them: syringes, catheters, surgical kits, but also consumables for diagnostic laboratories. They now have two equally valid routes until 10 May 2028. They can stay on EN ISO 11137-1:2015 with amendment EN ISO 11137-1:2015/A2:2019 or move to EN ISO 11137-1:2026. Anyone staying on the old version who wants to keep the presumption after 10 May 2028 must reassess their validated processes against the new version before then.

The second effect concerns clinical investigations. EN ISO 14155:2026 becomes the reference for good clinical practice in investigations of medical devices on human subjects, alongside EN ISO 14155:2020 with amendment EN ISO 14155:2020/A11:2024 until 10 May 2028. Sponsors and investigation sites in Romania that are now preparing a clinical investigation plan can choose the version, but an investigation that starts in 2026 and continues after May 2028 will straddle the change of reference.

The third effect is an extension of the presumption to products that until now had no reference published in support of Regulation (EU) 2017/745. Recital 5 states plainly that the earlier versions of the seven standards, for example EN ISO 4074:2015 for condoms or EN ISO 10993-7:2008 for ethylene oxide residuals, had not been published in support of the regulation. Manufacturers of condoms, of implants assessed for local effects, of devices sterilized with ethylene oxide, of washer-disinfectors for non-critical equipment, of laser equipment and of intense pulsed light or other non-laser light source equipment used in surgery, therapy or aesthetics now have a standardised way of demonstrating conformity, recognised in all Member States.

The fourth effect is on market surveillance. Notified bodies relate their assessments to the published references, and the National Agency for Medicines and Medical Devices of Romania, which supervises the market for medical devices, has an updated benchmark against which to compare a product’s technical documentation. A device that does not follow the standard does not thereby become non-compliant, but its manufacturer must show by other means that it meets the requirement.

What has changed compared with the previous situation

Until 9 November 2026, the list for medical devices had 65 entries, the last being the general standard for medical electrical equipment, EN 60601-1:2006 with amendment A13:2024. From 10 November 2026 the numbering runs to 72, and entries 3a and 39a are inserted among the existing entries, next to entries 3 and 39, which they will replace. On the list for in vitro diagnostic medical devices, entry 2a sits next to entry 2 until 10 May 2028, when entry 2 is deleted.

For radiation sterilization, the change is bigger than the year in the reference suggests. Entry 3 on the medical devices list and entry 2 on the in vitro diagnostic list carry EN ISO 11137-1:2015, and their title shows that the underlying ISO text is ISO 11137-1:2006, including Amendment 1:2013. The new reference is based on ISO 11137-1:2025. For clinical investigation, the gap is smaller: the move is from ISO 14155:2020 to ISO 14155:2026.

Several families of standards are being filled in. The EN ISO 10993 biological evaluation series already had parts 1, 4, 5, 9, 10, 12, 15, 17, 18 and 23 on the medical devices list; parts 6 and 7 are now added. The EN ISO 15883 washer-disinfector series had parts 1, 2, 3 and 7, all in their 2025 versions; part 6 is added. The EN ISO 80369 small-bore connector series had part 2, for breathing system applications; part 1, with the general requirements, now follows. Medical electrical equipment had the general standard EN 60601-1:2006 and part 2-83; parts 2-22 and 2-57 are added.

What has not changed is the legal basis. Both decisions are adopted under Article 10(6) of Regulation (EU) No 1025/2012 on European standardisation and on the basis of the same standardisation request, Commission Implementing Decision C(2021) 2406 of 14 April 2021. The general safety and performance requirements of the two regulations are not affected.

Advantages and disadvantages

What it improves

  • The 547-day period during which the old and new versions coexist gives manufacturers time to revalidate their sterilization processes without losing the presumption in the meantime.
  • Seven standards that until now did not confer the presumption in support of Regulation (EU) 2017/745 do so from 10 November 2026, including for very widespread products such as condoms and the laser and intense pulsed light equipment used in aesthetics.
  • Ethylene oxide sterilization residuals finally have a published standard, alongside the process standard EN ISO 11135:2014, which has been on the list from the start.
  • The radiation sterilization standard changes on the same day and with the same transition date on both lists, so a manufacturer that makes both medical devices and in vitro diagnostic devices has a single timetable.

What remains a problem

  • The date of 10 May 2028 sits in Article 2, far from entries 3 and 39, through a reference to points (1) and (3) of the Annex. Anyone reading only the consolidated list will not see that the old version has an end date.
  • In the Romanian version, the same standard, EN ISO 11137-1:2026, carries two Romanian titles that do not match in the two decisions published on the same day; the English version gives it one and the same title in both.
  • Neither decision says what happens to a clinical investigation started under EN ISO 14155:2020 that is still under way on 10 May 2028.
  • For entry 70, the base standard dates from 2020 and enters the list only together with amendment A11:2026, without the decision saying whether the presumption can be relied on for the base standard applied without the amendment.

Practical advice

  1. If your devices are sterilized by irradiation, ask the sterilization facility for a gap analysis between EN ISO 11137-1:2015 and EN ISO 11137-1:2026 and a revalidation timetable that ends before 10 May 2028. After that date, the presumption can be relied on only for the 2026 version.
  2. Update the list of standards in your technical documentation. For each standard, record the version you apply and the date until which it remains on the published list; for EN ISO 11137-1 and EN ISO 14155 that date is 10 May 2028.
  3. If you are preparing a clinical investigation, check with the notified body and the ethics committee which version of EN ISO 14155 they will accept for an investigation that runs beyond 10 May 2028, and write the chosen version into the clinical investigation plan.
  4. If you manufacture laser or non-laser light source equipment for surgery, therapy and aesthetics, apply the standard together with amendment A11:2026, because entries 70 and 71 list both in the same position.
  5. For in vitro diagnostic devices, the only change is the radiation sterilization standard. The rest of the list in Implementing Decision (EU) 2021/1195 is untouched.
  6. Read the list in its consolidated version on EUR-Lex, but check the transition date in Article 2 of each decision, where it actually sits. The official Romanian text of both decisions is reproduced in full below.

Frequently asked questions

What does the presumption of conformity mean in concrete terms?
That a device which complies with a harmonised standard whose reference has been published in the Official Journal of the European Union is considered to conform to the requirements of the regulation that the standard covers. The legal basis is Article 8(1) of Regulation (EU) 2017/745 and of Regulation (EU) 2017/746 respectively, cited in recital 1 of each decision. The practical effect concerns the burden of proof: the manufacturer no longer has to defend its method, and whoever challenges the device must show that the requirement is not met.
Can I still use EN ISO 11137-1:2015 or EN ISO 14155:2020?
Yes, until 10 May 2028. Article 2 of Decision 2026/2479 defers until that date points (1) and (3) of the Annex, which delete the entries with the old versions, and Article 2 of Decision 2026/2481 does the same for EN ISO 11137-1:2015 on the in vitro diagnostic list. From 10 May 2028, the presumption can be relied on only for the 2026 versions.
From when do the new standards apply?
From 10 November 2026, the date on which both decisions were published in the Official Journal of the European Union, L series. Recital 13 of Decision 2026/2479 and recital 11 of Decision 2026/2481 explain why entry into force coincides with publication: the presumption runs from the day the reference of the standard is published.
Are the listed standards mandatory?
No. They provide a safe route to demonstrating conformity, without ruling out other methods. A manufacturer may follow another method, but must then show for itself that the device meets the requirement of the regulation.
What changes for in vitro diagnostic medical devices?
A single entry: EN ISO 11137-1:2026, for radiation sterilization, is inserted as entry 2a in the list in Implementing Decision (EU) 2021/1195, while the 2015 version, entry 2, leaves the list from 10 May 2028. The other new standards concern only medical devices governed by Regulation (EU) 2017/745.
Who is affected in Romania?
Manufacturers, authorised representatives, importers and distributors placing medical devices and in vitro diagnostic devices on the market, facilities that sterilize by irradiation or with ethylene oxide, sponsors and clinical investigation sites, notified bodies and the National Agency for Medicines and Medical Devices of Romania, in its market surveillance role.
Will patients notice any difference?
Not directly. The decisions do not change the safety requirements for devices or what is printed on the packaging. They change the standards by which the manufacturer proves that the device meets those requirements, from the sterilization of a syringe to the safety of the laser equipment in an aesthetic clinic.

Editorial analysis

Both acts are clean and need no corrigendum. Each has two articles, one referring to the Annex and one setting the entry into force and the transition date, and the cross-references hold: points (1) and (3) of the Annex to Decision 2026/2479 are indeed the ones that delete entries 3 and 39, and point (1) of the Annex to Decision 2026/2481 does indeed delete entry 2. The seven standards listed in recital 6 are exactly the seven new entries, 66-72, and the numbering correctly starts after entry 65, the last on the list in force before 10 November 2026.

The first observation only becomes visible in the list the decisions amend. The title of entry 3 shows that EN ISO 11137-1:2015 reproduces ISO 11137-1:2006, including Amendment 1:2013. With the 547-day transition, the radiation sterilization of medical devices will, until 10 May 2028, have based its presumption of conformity on an ISO text whose core is 22 years old. The transition is justified for validated processes, but it shows how slowly an ISO revision reaches the European list: ISO 11137-1:2025 appears in the Official Journal of the European Union only in November 2026.

The second observation emerges from a comparison with the consolidated list. Several families of standards reached the list in the reverse of their logical order. Part 2 of EN ISO 80369, for breathing system connectors, was already listed, as entry 48, before part 1, with the general requirements, which arrives only now. The process standard for ethylene oxide sterilization, EN ISO 11135:2014, has been on the list from the start, but the standard for the residuals of that sterilization, EN ISO 10993-7, enters only in 2026. And the EN ISO 15883 series still lacks parts 4 and 5, although parts 1, 2, 3, 6 and 7 are now published.

The third observation concerns how the two acts of the same day are worded in the Romanian version. In Romanian, EN ISO 11137-1:2026 appears in Decision 2026/2479 under the title “Sterilizarea dispozitivelor pentru îngrijirea sănătății. Iradiere. Partea 1: Cerințe pentru implementare, validare și control de rutină pentru procesul de sterilizare a dispozitivelor medicale”, and in Decision 2026/2481 with the segments separated by dashes, as in the old entry, and with “procese de sterilizare”, in the plural. Recital 3 of the Romanian version of Decision 2026/2481 also speaks of “sterilizarea produselor de îngrijire a sănătății”, the sterilization of health care products. The English version has no such discrepancy: both decisions give the standard the same title, the one quoted in the list above. The reference is identical, so there is no legal doubt as to the standard, but anyone looking for the exact Romanian title for a declaration of conformity will find two official variants.

What should be changed

  • The withdrawal date written into the old entry itself. A note along the lines of “the reference is withdrawn on 10 May 2028” next to entries 3 and 39 and next to entry 2 on the in vitro diagnostic list. Anyone consulting the consolidated list would see the deadline without having to look up Article 2 of an amending decision.
  • A rule for clinical investigations under way. A sentence stating whether an investigation started under EN ISO 14155:2020 keeps its presumption until it is completed. Sponsors would no longer need to change their reference in the middle of an investigation or obtain an interpretation from each notified body separately.
  • A single Romanian title for EN ISO 11137-1:2026. A corrigendum aligning the Romanian title in Decision 2026/2481 with the one in Decision 2026/2479, or vice versa, as the English version already does. Romanian declarations of conformity and technical documentation would then cite a single official form.
  • Clarification of the relationship between the base standard and the amendment in entries 70 and 71. Wording such as “EN IEC 60601-2-22:2020, as amended by A11:2026” would show that the presumption operates only for the combination. A manufacturer of laser equipment could then no longer rely on the 2020 standard applied on its own.
  • A public list of the standards still in preparation in the same families. The Commission could indicate, in the recitals or on the page of the standardisation request, which parts of the EN ISO 15883 or EN ISO 10993 series are to follow. Manufacturers of washer-disinfectors, for example, could then plan their revalidations on a timetable known in advance.

Original text of the legal act

The text below is reproduced in Romanian, the official form of publication.

The full text, as published in the Official Gazette of Romania

Official Journal of the European Union, L series, 2026/2479 and 2026/2481 of 10 November 2026; ELI: http://data.europa.eu/eli/dec_impl/2026/2479/oj and http://data.europa.eu/eli/dec_impl/2026/2481/oj; CELEX 32026D2479 and 32026D2481 4 pages PDF, 478 KB

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This article is for informational purposes only and does not constitute legal advice. For specific situations, consult a licensed attorney or tax advisor.