INSTITUTION PROFILE / BIOSENSORS
European Commission
The proposer of the EU's device regulations (MDR and IVDR) and coordinator of how they run; notified bodies, not the Commission, certify products
To sell a biosensor product such as a blood glucose meter or a continuous glucose monitor (CGM) in the EU, a manufacturer must follow the Medical Device Regulation (MDR, Regulation (EU) 2017/745) or the In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746), go through conformity assessment by a notified body where the risk class requires it, and affix the CE marking. The European Commission is the body that proposed both regulations. Since adoption it has kept them running through joint assessments of notified bodies, standardisation requests, the EUDAMED database, and chairing and supporting the Medical Device Coordination Group (MDCG) of national authorities. It does not, however, certify products itself. This profile looks at one question only: how much influence the Commission has over biosensors. It contains no advice on how to use any product or on any reader's personal health.
What this article covers
- The European Commission in 30 seconds
- What kind of body it is: the four types of influence
- What it does for biosensors
- How far its influence reaches (powers and geography)
- Companies and organisations involved
- Outlook
- Glossary, references and claim-to-source audit
1. The European Commission in 30 seconds
FULL NAMEEuropean CommissionMedical devices fall to its Directorate-General for Health and Food Safety (DG SANTE). The Commissioner responsible is Olivér Várhelyi (per the Parliament's Legislative Observatory)
REGIONEuropean UnionThe MDR and IVDR are texts with EEA relevance. DG SANTE's postal address is Brussels, Belgium
TYPE OF BODYAn EU institutionIt proposes laws and coordinates how adopted regulations are applied. The Parliament and the Council adopt the regulations
MAKING THE MDR AND IVDRProposed 26 Sep 2012 / published 5 May 2017Parliament's second-reading adoption was on 5 April 2017
STAFFAbout 33,000Permanent and contract staff across the whole Commission (its own description). DG SANTE's headcount could not be confirmed
NOTIFIED BODIESMDR: 51 / IVDR: 19Designated bodies, as stated in the Commission's December 2025 proposal
ROLE IN BIOSENSORSProposing the rules and coordinating themMDCG chair, joint assessment of notified bodies, standardisation requests, EUDAMED, implementing acts
REACHEvery manufacturer selling in the EU and EEAMakers outside the EU need an authorised representative. It does not reach other countries' rules
The one thing to grasp first
EU conformity assessment takes place between the manufacturer and a notified body. The body that designates notified bodies is a Member State authority; the Commission sends experts to the joint assessment team and publishes the designation in the NANDO database Sourced. The Commission never "approves" a product. That differs from systems such as the U.S. or Japan, where a central authority approves or clears individual products. The EU also has the European Medicines Agency (EMA) for medicines and the European Chemicals Agency (ECHA) for chemicals, but certifying products under the MDR and IVDR is the job of neither (the EMA appears only in a proposal to support expert panels).
2. What kind of body it is: the four types of influence
The "institutions" that appear in articles on biosensors (medical devices and in vitro diagnostics) do not make products the way companies do. They can be sorted into four types by the route through which they influence the industry. The European Commission is a "policy and regulation" body.
3. What it does for biosensors
In the EU's device system the roles are divided as follows. The Commission's work is to frame the system and keep its operation consistent; decisions on individual products are taken by notified bodies and national authorities Sourced.
| Role | Who performs it | What the primary sources say |
|---|---|---|
| Making the regulations | The Commission proposes; the European Parliament and the Council adopt | The Commission proposed the MDR and IVDR on 26 September 2012 (COM(2012) 542 and 541). They were adopted on 5 April 2017 and published on 5 May 2017. The MDR applies from 26 May 2021 (postponed by a year from the original 2020) and the IVDR from 26 May 2022 |
| Certifying products | Notified bodies (private) | Depending on risk class, a manufacturer involves an independent notified body in conformity assessment and then affixes the CE marking. The Commission does not certify |
| Designating notified bodies | Member State authorities (the Commission joins the joint assessment and publishes) | A Member State designates a body and notifies the Commission and other Member States. The Commission sets up a joint assessment team with experts and, if there are no objections, publishes the designation in NANDO. Objections may be raised within 28 days of notification |
| Keeping practice consistent | The MDCG (Member State representatives), chaired by a Commission representative | The MDCG drafts guidance, advises on the assessment of notified bodies and helps coordinate classification. The Commission organises its meetings and gives technical and scientific support. Guidance is not legally binding |
| Role of standards | CEN and CENELEC (writing); the Commission (requesting and publishing) | On 14 April 2021 the Commission issued a standardisation request (M/575) to CEN and CENELEC. Once references to harmonised standards are published in the Official Journal, voluntary use of them gives a presumption of conformity with the regulations |
| Database | The Commission (EUDAMED) | Since 28 May 2026 four modules have been mandatory to use: actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. Two remaining modules are in development |
| Expert panels | The Commission | In consultation with the MDCG, the Commission designates expert panels for the assessment of clinical evaluation and related advice |
| Market surveillance | Member State competent authorities (the Commission supports coordination) | Competent authorities cooperate with each other and with the Commission, which organises the exchange of information |
Basis: MDR Articles 11, 35 to 42 and 102 to 106, the IVDR, the Commission's medical devices and EUDAMED pages, and the Legislative Observatory (references 1, 2, 4 to 9 and 13 to 16). The table is our own summary.
Classes and transition periods: what is needed by when
| Topic | What the primary sources say | Category |
|---|---|---|
| Risk classes | Medical devices (MDR) fall in classes I, IIa, IIb and III; in vitro diagnostic devices (IVDR) in classes A, B, C and D (as described in the Commission's proposal) | Sourced |
| Self-testing | IVDR classification rule 4: devices for self-testing are class C by default. The exceptions classed as B are pregnancy tests, fertility tests, cholesterol determination and devices detecting glucose, erythrocytes, leucocytes and bacteria in urine. Near-patient testing devices (used by a professional outside a laboratory) are classified in their own right. Classification of an individual product is worked through with MDCG 2020-16 (fifth revision, September 2026) | Sourced |
| MDR transition (certificates under the old directives) | Devices with a certificate under the old directives may be placed on the market until 31 December 2027 for all class III and implantable class IIb devices (with some exceptions), and until 31 December 2028 for other class IIb, class IIa and certain class I devices. Conditions include a quality management system and a formal application to a notified body by 26 May 2024 | Sourced |
| IVDR transition | Devices with a certificate under the old directive may be placed on the market until 31 December 2027. Devices that needed no notified body under the old directive may be marketed until 31 December 2027 (class D), 31 December 2028 (class C) and 31 December 2029 (class B, and class A supplied sterile). Each comes with conditions, such as a quality management system by 26 May 2025 and dated applications to a notified body | Sourced |
| How the extensions came about | Regulation 2020/561 postponed the MDR's application. Regulations 2022/112 and 2024/1860 extended IVDR transition periods, and Regulation 2023/607 extended the MDR's | Sourced |
A materials engineer's view: harmonised standards are the route to presumption of conformity
In the EU, voluntary use of a harmonised standard gives a presumption of conformity with the regulation's requirements. The IVDR decisions in which the Commission published references include EN ISO 13485:2016 (quality management), EN ISO 14971:2019 (risk management), EN ISO 17511:2021 (metrological traceability of values assigned to calibrators and control materials) and the EN ISO 18113 series (information supplied by the manufacturer) Sourced. The blood glucose performance standard ISO 15197, however, did not appear in any of the nine IVDR publication decisions we checked. Which standards can be relied on changes as publications are updated, so a real design needs the latest publication checked.
| Topic | What the primary sources say | Category |
|---|---|---|
| Number of notified bodies | The Commission's proposal (December 2025): 51 bodies designated under the MDR and 19 under the IVDR. DG SANTE's 2026 management plan sets targets of 53 and 20 designations in NANDO | Sourced |
| Standardising notified body procedures | Commission Implementing Regulation (EU) 2026/977 (4 May 2026, applying from 25 February 2027) sets maximum timelines for notified bodies' conformity assessment: 30 days for application review and signing the contract, 120 days for quality management system auditing, 90 days for product verification and 20 days for the decision and certificate. It also specifies what a quotation must contain | Sourced |
4. How far its influence reaches (powers and geography)
| Aspect | What the Commission has | What it does not have |
|---|---|---|
| Powers | The right to propose regulations (including amendments). Setting detailed rules by implementing act, within the scope the MDR and IVDR give it. Chairing the MDCG and supporting its work. Sending experts to joint assessment teams for notified bodies, publishing designations in NANDO and raising objections to designations. Requesting standards and publishing references. Building and running EUDAMED. Designating expert panels | Approving or certifying products (the work of notified bodies). Designating notified bodies (Member State authorities). Adopting the regulations themselves (the Parliament and the Council). Enforcing market surveillance (national competent authorities). Giving MDCG guidance legal force |
| Geography | Devices sold in the EU and EEA. A manufacturer outside the EU can place a device on the Union market only by designating a sole authorised representative. In July 2024 it also held an information session on the MDR and IVDR for international regulators | Whether a device may be sold in Japan, the U.S. or elsewhere, and other regulators' decisions |
| Scale | About 33,000 staff across the Commission. DG SANTE is headed by a Director-General. 51 notified bodies under the MDR and 19 under the IVDR (December 2025) | We could not confirm how many DG SANTE staff work on medical devices |
| Detailed rules | In 2026 it published Implementing Regulation (EU) 2026/977, which unifies notified bodies' procedural timelines and the content of quotations | Issuing individual certificates (done by notified bodies) |
Note: implementing acts are adopted through the committee (examination) procedure in MDR Article 114. The staff figure is the Commission's own statement of about 33,000 permanent and contract staff.
5. Companies and organisations involved
The figure below puts the Commission at the centre and shows which organisation does what under the MDR and IVDR. The arrows show only relationships that primary sources record.
| Organisation | Relationship with the Commission (what primary sources confirm) | Category |
|---|---|---|
| Notified bodies | 51 under the MDR and 19 under the IVDR (December 2025). Member States designate them, and the Commission takes part in joint assessment and publication. This profile does not name individual bodies | Sourced |
| Member State authorities | They designate notified bodies and act as competent authorities for market surveillance. They cooperate with the Commission and send representatives to the MDCG | Sourced |
| CEN and CENELEC | They write harmonised standards in response to the Commission's standardisation request M/575 (14 April 2021) | Sourced |
| European Medicines Agency (EMA) | Not a regulator of devices. The Commission's December 2025 proposal includes amending Regulation (EU) 2022/123 on the EMA's support for the expert panels | Sourced |
| Companies | The Commission documents we checked contain no decisions on individual companies' products. Companies obtain certification from notified bodies | Sourced |
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| On 16 December 2025 the Commission proposed a targeted simplification of the MDR and IVDR (COM(2025) 1023). It is now at committee stage in the European Parliament and has not been adopted | The Legislative Observatory: the rapporteur was appointed on 13 February 2026, amendments were tabled on 28 July 2026, and the indicative date for the first-reading plenary is 14 December 2026. The European Economic and Social Committee adopted its opinion on 29 April 2026 | Not yet confirmed |
| The proposal would remove the five-year maximum validity of certificates (replacing recertification with risk-proportionate periodic reviews), revise the conditions for in-house devices (for the IVDR, dropping the condition that no equivalent device is on the market), and adapt some classification rules, including for software | The explanatory material of COM(2025) 1023. These are proposals and may change in the Parliament and the Council. As proposed, it would apply six months after entry into force, with some items phased in | Not yet confirmed |
| Under current law, transition deadlines fall between 31 December 2027 and 31 December 2029, depending on class and certificate status | MDR Article 120 and IVDR Article 110 (consolidated versions of 10 January 2025) | Sourced |
| Implementing Regulation (EU) 2026/977, which sets maximum timelines for notified bodies, will apply from 25 February 2027 | Implementing Regulation (EU) 2026/977 (4 May 2026) | Sourced |
| Four EUDAMED modules have been mandatory since 28 May 2026; the two remaining modules (post-market surveillance and vigilance; clinical investigations and performance studies) are in development, and we could not confirm when they become mandatory | The Commission's EUDAMED page and Decision (EU) 2025/2371 of 26 November 2025 | Not yet confirmed |
| Depending on when the proposal is adopted, the text may change before the transition deadlines at the end of 2027 and later | The timetable in the row above and the current transition deadlines. No adoption date has been published | Inference |
| The guidance on classifying in vitro diagnostic devices was revised in September 2026 (MDCG 2020-16, fifth revision), and the guidance on classifying medical devices in April 2026 (MDCG 2021-24, revision 1) | The Commission's guidance page. The guidance is not legally binding | Sourced |
7. Glossary
- MDR
- Regulation (EU) 2017/745, the EU Medical Device Regulation. It applies from 26 May 2021.
- IVDR
- Regulation (EU) 2017/746, the EU In Vitro Diagnostic Regulation. It applies from 26 May 2022.
- Notified body
- A private conformity assessment body designated by a Member State. It issues certificates for devices that need third-party assessment.
- MDCG
- The Medical Device Coordination Group, made up of Member State representatives and chaired by a Commission representative. It drafts guidance.
- Harmonised standard
- A European standard whose reference is published in the Official Journal. Voluntary use gives a presumption of conformity with the regulation.
- EUDAMED
- The European database on medical devices, run by the Commission. It covers actors, devices, certificates and market surveillance.
- NANDO
- The Commission's database of notified bodies.
- Authorised representative
- The sole EU-based representative a manufacturer outside the EU must designate. It keeps compliance documents and deals with authorities.
- Implementing act
- A legal act through which the Commission sets detailed rules under a basic act, here the MDR and IVDR.
8. References
- EUR-Lex Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR): Articles 11, 35 to 42, 102 to 106, 120 and others. https://eur-lex.europa.eu/eli/reg/2017/745/oj
- EUR-Lex Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR): Article 110 and Annex VIII, rule 4. https://eur-lex.europa.eu/eli/reg/2017/746/oj
- EUR-Lex Consolidated text of the MDR as of 10 January 2025: current transitional provisions in Article 120. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20250110
- EUR-Lex Consolidated text of the IVDR as of 10 January 2025: current transitional provisions in Article 110 and classification rule 4. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110
- EUR-Lex Regulation (EU) 2020/561: postponing the MDR's date of application from 26 May 2020 to 26 May 2021. https://eur-lex.europa.eu/eli/reg/2020/561/oj
- EUR-Lex Regulation (EU) 2022/112: extending IVDR transitional provisions. https://eur-lex.europa.eu/eli/reg/2022/112/oj
- EUR-Lex Regulation (EU) 2023/607: extending the transitional provisions of the MDR and IVDR. https://eur-lex.europa.eu/eli/reg/2023/607/oj
- EUR-Lex Regulation (EU) 2024/1860: gradual roll-out of Eudamed and IVDR transitional provisions. https://eur-lex.europa.eu/eli/reg/2024/1860/oj
- EUR-Lex Commission Implementing Regulation (EU) 2026/977 of 4 May 2026: uniform quality management and procedural requirements for notified bodies (applying from 25 February 2027). https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
- European Commission COM(2025) 1023 final (16 December 2025): proposal to simplify the MDR and IVDR, with notified body numbers, transition deadlines and an outline of the amendments. https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf
- European Parliament Legislative Observatory Procedure 2025/0404(COD): status of the above proposal (rapporteur, amendments, indicative plenary date). https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0404(COD)
- European Parliament Legislative Observatory Procedure 2012/0266(COD): legislative history of the MDR (proposal 26 September 2012, adopted 5 April 2017, published 5 May 2017). https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2012/0266(COD)
- European Parliament Legislative Observatory Procedure 2012/0267(COD): legislative history of the IVDR. https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2012/0267(COD)
- European Commission Medical Devices - Sector (managed by DG SANTE): the IVDR's application and the information session for international regulators. https://health.ec.europa.eu/medical-devices-sector_en
- European Commission Medical Devices - EUDAMED Overview: four modules mandatory from 28 May 2026 (Decision (EU) 2025/2371). https://health.ec.europa.eu/medical-devices-eudamed/overview_en
- European Commission Guidance - MDCG endorsed documents and other guidance: MDCG documents are not legally binding; MDCG 2020-16 rev.5 and MDCG 2021-24 rev.1. https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
- European Commission Harmonised standards: standardisation request M/575, publication of references and presumption of conformity, and the list of publication decisions. https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en
- EUR-Lex Commission Implementing Decision (EU) 2022/15: additions to the IVDR harmonised standards (EN ISO 13485:2016/A11:2021, EN ISO 17511:2021 and others). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0015
- EUR-Lex Commission Implementing Decision (EU) 2026/197: additions to the IVDR harmonised standards (the EN ISO 18113 series and others). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026D0197
- European Commission DG SANTE Management Plan 2026: 2026 targets (53 and 20 notified body designations, mandatory Eudamed use, negotiations on the revision). https://commission.europa.eu/document/download/4a5ae74d-2749-45f6-bb80-91a4b4e75054_en?filename=sante_mp_2026_en.pdf
- European Commission Commission staff: about 33,000 permanent and contract staff. https://commission.europa.eu/about/organisation/commission-staff_en
- European Commission Health and Food Safety: DG SANTE's responsibilities, Director-General and postal address. https://commission.europa.eu/about/departments-and-executive-agencies/health-and-food-safety_en
- EUR-Lex Commission Implementing Decision (EU) 2022/729: addition of EN ISO 14971:2019 to the IVDR harmonised standards. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0729
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| The proposal (26 September 2012), adoption (5 April 2017) and publication (5 May 2017) of the MDR and IVDR | Sourced | Reference 12 https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2012/0266(COD) Reference 13 https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2012/0267(COD) |
| The MDR's date of application (26 May 2021, postponed from 2020) and the IVDR's (26 May 2022) | Sourced | Reference 1 https://eur-lex.europa.eu/eli/reg/2017/745/oj Reference 2 https://eur-lex.europa.eu/eli/reg/2017/746/oj Reference 5 https://eur-lex.europa.eu/eli/reg/2020/561/oj Reference 10 https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf Reference 14 https://health.ec.europa.eu/medical-devices-sector_en |
| Notified bodies are designated by Member State authorities; the Commission's joint assessment team, publication in NANDO and the objection period | Sourced | Reference 1 https://eur-lex.europa.eu/eli/reg/2017/745/oj |
| The MDCG's composition (Member State representatives, chaired by the Commission), tasks, expert panels and cooperation of competent authorities | Sourced | Reference 1 https://eur-lex.europa.eu/eli/reg/2017/745/oj |
| MDCG guidance is not legally binding; MDCG 2020-16 rev.5 and MDCG 2021-24 rev.1 | Sourced | Reference 16 https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en |
| The authorised representative requirement for manufacturers outside the EU | Sourced | Reference 1 https://eur-lex.europa.eu/eli/reg/2017/745/oj |
| Standardisation request M/575 (14 April 2021), publication of references and the presumption of conformity | Sourced | Reference 17 https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en |
| EN ISO 13485, 14971, 17511 and 18113 among the IVDR harmonised standards, and ISO 15197 absent from the nine publication decisions we checked | Sourced | Reference 17 https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en Reference 18 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0015 Reference 19 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026D0197 Reference 23 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0729 |
| Four EUDAMED modules mandatory from 28 May 2026, and the status of the remaining two | Sourced | Reference 15 https://health.ec.europa.eu/medical-devices-eudamed/overview_en |
| Risk classes, IVDR classification rule 4 (self-testing devices default to class C) and near-patient testing | Sourced | Reference 2 https://eur-lex.europa.eu/eli/reg/2017/746/oj Reference 4 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 Reference 10 https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf |
| The MDR transition periods (31 December 2027 and 2028) and conditions | Sourced | Reference 3 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20250110 |
| The IVDR transition periods (2027 to 2029) and conditions | Sourced | Reference 4 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20250110 |
| The regulations extending or postponing the dates (2020/561, 2022/112, 2023/607, 2024/1860) | Sourced | Reference 5 https://eur-lex.europa.eu/eli/reg/2020/561/oj Reference 6 https://eur-lex.europa.eu/eli/reg/2022/112/oj Reference 7 https://eur-lex.europa.eu/eli/reg/2023/607/oj Reference 8 https://eur-lex.europa.eu/eli/reg/2024/1860/oj Reference 10 https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf |
| Numbers of notified bodies (MDR 51, IVDR 19; December 2025) | Sourced | Reference 10 https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf |
| The 2026 targets for notified body designations (53 and 20), the negotiations on the revision and DG SANTE's premises | Sourced | Reference 20 https://commission.europa.eu/document/download/4a5ae74d-2749-45f6-bb80-91a4b4e75054_en?filename=sante_mp_2026_en.pdf |
| Implementing Regulation (EU) 2026/977: maximum timelines (30, 120, 90 and 20 days) and the application date (25 February 2027) | Sourced | Reference 9 https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj |
| The Commission's staff (about 33,000), DG SANTE's responsibilities, address and Commissioner | Sourced | Reference 21 https://commission.europa.eu/about/organisation/commission-staff_en Reference 22 https://commission.europa.eu/about/departments-and-executive-agencies/health-and-food-safety_en Reference 11 https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0404(COD) |
| The content of the proposal COM(2025) 1023 (certificate validity, in-house devices, classification rules, EMA support, application date) | Sourced | Reference 10 https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf |
| The status of the proposal (rapporteur, amendments, plenary date, EESC opinion) | Not yet confirmed | Reference 11 https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0404(COD) |
| The EMA is not a device regulator and is proposed only to support expert panels | Sourced | Reference 10 https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf |
| The four types of institution, and the layout of Fig. 2 | Our calculation | Our own classification |
| When the proposal will be adopted and its final content | Not yet confirmed | Not stated in the references; this article does not estimate it |
| When the two remaining EUDAMED modules become mandatory | Not yet confirmed | Not stated in the references; this article does not estimate it |
| How many DG SANTE staff work on medical devices | Not yet confirmed | Not stated in the references; this article does not estimate it |
| The inference in section 6 | Inference | This article's reading of references 3, 4, 10 and 11 |
Last updated 4 October 2026 / Troy Technical
All figures come from the text of the MDR and IVDR and their amending acts, the Commission's official pages, proposal and management plan, and the European Parliament's Legislative Observatory. Items marked "Inference" are this article's reading of the primary information. Nothing here is advice on how to use any product or on any reader's personal health.