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European Union medical device regulations

Official sources linked

EU MDR rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.

17 documents6 categories100% linked to official sourcesauthority EU MDR16 readable HTML
CodeRegulationCategoryEffectiveProvenance
Regulation (EU) 2017/746
In Vitro Diagnostic Medical Devices Regulation
Authentic Official Journal expression of the IVDR. Ingested from EUR-Lex CONVEX HTML for CELEX 32017R0746. Date of the act is 5 April 2017; OJ L 117/176 publication is 5 May 2017.
GeneralMay 26, 2022Official
Regulation (EU) 2022/112
Amendment to IVDR transitional periods
Amending regulation, date of the act 25 January 2022, OJ L 19/3 publication 28 January 2022. Article 2: enters into force on the day of OJ publication.
GeneralJanuary 28, 2022Official
EUDAMED user guide — Production v2.27.0 (2026)
EUDAMED user guide — Actor module for Economic Operators
Complete 98-page official EUDAMED economic-operator Actor module user guide, cover Production v2.27.0 / 2026. Body expressly covers MDR and IVDR economic actors. Preserves actor-detail updating, Local Actor Administrator restriction, tax/trade-ID decision tree and pending-request restrictions, plus complete surrounding guide and screenshots. Actor data versioning and platform effects do not establish device certificate approval, legal-entity succession, manufacturer ownership-transfer approval or universal change-review timing. The interface is expressly described as evolving. Raw transport is complete GET200/TLS0; Poppler emits a retained nonfatal stream warning, with all 98 pages and native pages successfully processed. No date is inferred from HTTP Last-Modified or PDF creation metadata. Complete unchanged official PDF, with every original physical page image mandatory and authoritative. Exact native PDF text is an incomplete search layer and retains extraction artifacts; original images preserve tables, screenshots, flowcharts and footnotes. Source preservation does not establish consolidated currentness, universal applicability, a new fact, or completion of any QBD scenario. No publication or effective date is inferred from file properties.
Registration—Official
Regulation (EU) 2017/746 (consolidated)
In Vitro Diagnostic Regulation — consolidated 10 January 2025
EUR-Lex consolidated expression 02017R0746-20250110 — still the newest official IVDR consolidation: every 02017R0746 expression in the Publications Office Cellar was enumerated via SPARQL on 29 August 2026 and none is dated later than 10 January 2025. Kept distinct from the authentic OJ text. Recitals are omitted from this consolidation, as EUR-Lex states.
General—Official
MDCG 2018-1 Rev.4
Guidance on BASIC UDI-DI and changes to UDI-DI
Complete 4-page nonbinding MDCG guidance, printed April 2021, expressly addressing both MDR and IVDR UDI systems. Preserves name/trade-name/model triggers, misidentification and traceability qualification, direct-marking/UDI-PI/reuse conditions and footnotes on colour/language. Page 4 expressly excludes reprocessed devices, systems/procedure packs, software, Annex XVI, parallel trade and own-brand labelling. Does not decide whether a specific REF/logo change is a new device or give general registration/stock/fee/transfer permission. Complete unchanged official PDF, with every original physical page image mandatory and authoritative. Exact native PDF text is an incomplete search layer and retains extraction artifacts; original images preserve tables, screenshots, flowcharts and footnotes. Source preservation does not establish consolidated currentness, universal applicability, a new fact, or completion of any QBD scenario. No publication or effective date is inferred from file properties.
UDI—Official
MDCG 2022-6
Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
Complete 17-page nonbinding MDCG guidance, printed May 2022, limited to legacy IVDD devices under the stated IVDR Article 110 transitional scope. Manufacturer-organisation examples, certificate/QMS notification conditions and all decision charts remain intact. Its historical transition dates, including the page 5 May 2025 wording, are preserved but not treated as current deadlines after later legislation. This exact captured system/files URL is not silently aliased to the different UUID link now listed on the official index. No blanket manufacturer-transfer or universal IVDR change route is inferred. Complete unchanged official PDF, with every original physical page image mandatory and authoritative. Exact native PDF text is an incomplete search layer and retains extraction artifacts; original images preserve tables, screenshots, flowcharts and footnotes. Source preservation does not establish consolidated currentness, universal applicability, a new fact, or completion of any QBD scenario. No publication or effective date is inferred from file properties.
Registration—Official
Exports carry source + retrieval date

Changes after registration in European Union

Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval
  • Supporting documents

IVDR: notified-body assessment of substantial QMS or device-range changes

Fact-level verified

The manufacturer must inform the notified body that approved its QMS of planned substantial changes to that QMS or the covered device range. The notified body assesses the proposed changes and any need for additional audits; approval takes the form of a supplement to the EU QMS certificate.

Conditions
  • Apply only to the Annex IX certified QMS/device-range route and a change that meets its substantial-change trigger.
  • A logo, office address or internal order-number edit is not classified as a substantial QMS change merely because it appears in the question.
  • The clause supplies no fixed best/expected/worst assessment time and no automatic combined-filing permission.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

  • Filing route and prior approval

IVDR: own-name supply and manufacturer obligations

Fact-level verified

A distributor, importer or other person assumes manufacturer obligations if it makes a device available under its own name, registered trade name or registered trade mark. The clause has an exception where a distributor/importer has an agreement under which the manufacturer is identified as such on the label and remains responsible for meeting the Regulation’s manufacturer requirements.

Conditions
  • Assess the actual legal actor and the Article 16(1)(a) agreement exception; do not treat every cosmetic logo change as a new legal manufacturer.
  • This is a role/responsibility rule; it does not itself establish that a certificate or registration can be transferred to another legal entity.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

  • Labels and identifiers

IVDR: manufacturer and authorised representative label identity

Fact-level verified

The label must state the manufacturer’s name, registered trade name or registered trade mark and the address of its registered place of business. For a manufacturer outside the Union, it must also state the authorised representative’s name and registered business address.

Conditions
  • This is a label-content obligation, not a standalone authority change-approval route.
  • A registered office/address change is assessed separately from a physical production-site change.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

Conditions for this question

  • Apply this manufacturer/authorised-representative identity rule only when the actual change affects the displayed manufacturer name, registered trade name/trade mark, registered address or authorised-representative details; device branding alone requires its own assessment.
  • Labels and identifiers

IVDR: name, trade name or model changes and a new UDI-DI

Fact-level verified

A new UDI-DI is required for a change that could cause device misidentification or ambiguity in traceability. The expressly listed triggers include changes to the device name or trade name and the device version or model.

Conditions
  • First determine what the changed SMN/REF represents: an internal order number alone is not automatically a change of device model or version.
  • This concerns UDI identification; no new Basic UDI-DI, conformity certificate or approval period is automatically inferred.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

Change control →Label, IFU & language →UDI, listing & traceability →

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval
  • Supporting documents

IVDR: notified-body assessment of substantial QMS or device-range changes

Fact-level verified

The manufacturer must inform the notified body that approved its QMS of planned substantial changes to that QMS or the covered device range. The notified body assesses the proposed changes and any need for additional audits; approval takes the form of a supplement to the EU QMS certificate.

Conditions
  • Apply only to the Annex IX certified QMS/device-range route and a change that meets its substantial-change trigger.
  • A logo, office address or internal order-number edit is not classified as a substantial QMS change merely because it appears in the question.
  • The clause supplies no fixed best/expected/worst assessment time and no automatic combined-filing permission.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

  • Filing route and prior approval

IVDR: own-name supply and manufacturer obligations

Fact-level verified

A distributor, importer or other person assumes manufacturer obligations if it makes a device available under its own name, registered trade name or registered trade mark. The clause has an exception where a distributor/importer has an agreement under which the manufacturer is identified as such on the label and remains responsible for meeting the Regulation’s manufacturer requirements.

Conditions
  • Assess the actual legal actor and the Article 16(1)(a) agreement exception; do not treat every cosmetic logo change as a new legal manufacturer.
  • This is a role/responsibility rule; it does not itself establish that a certificate or registration can be transferred to another legal entity.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

  • Labels and identifiers

IVDR: manufacturer and authorised representative label identity

Fact-level verified

The label must state the manufacturer’s name, registered trade name or registered trade mark and the address of its registered place of business. For a manufacturer outside the Union, it must also state the authorised representative’s name and registered business address.

Conditions
  • This is a label-content obligation, not a standalone authority change-approval route.
  • A registered office/address change is assessed separately from a physical production-site change.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

Change control →Economic-operator roles →Label, IFU & language →

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval
  • Supporting documents

IVDR: notified-body assessment of substantial QMS or device-range changes

Fact-level verified

The manufacturer must inform the notified body that approved its QMS of planned substantial changes to that QMS or the covered device range. The notified body assesses the proposed changes and any need for additional audits; approval takes the form of a supplement to the EU QMS certificate.

Conditions
  • Apply only to the Annex IX certified QMS/device-range route and a change that meets its substantial-change trigger.
  • A logo, office address or internal order-number edit is not classified as a substantial QMS change merely because it appears in the question.
  • The clause supplies no fixed best/expected/worst assessment time and no automatic combined-filing permission.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

  • Labels and identifiers

IVDR: manufacturer and authorised representative label identity

Fact-level verified

The label must state the manufacturer’s name, registered trade name or registered trade mark and the address of its registered place of business. For a manufacturer outside the Union, it must also state the authorised representative’s name and registered business address.

Conditions
  • This is a label-content obligation, not a standalone authority change-approval route.
  • A registered office/address change is assessed separately from a physical production-site change.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

Change control →Economic-operator roles →Label, IFU & language →

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval
  • Supporting documents

IVDR: notified-body assessment of substantial QMS or device-range changes

Fact-level verified

The manufacturer must inform the notified body that approved its QMS of planned substantial changes to that QMS or the covered device range. The notified body assesses the proposed changes and any need for additional audits; approval takes the form of a supplement to the EU QMS certificate.

Conditions
  • Apply only to the Annex IX certified QMS/device-range route and a change that meets its substantial-change trigger.
  • A logo, office address or internal order-number edit is not classified as a substantial QMS change merely because it appears in the question.
  • The clause supplies no fixed best/expected/worst assessment time and no automatic combined-filing permission.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

  • Labels and identifiers

IVDR: name, trade name or model changes and a new UDI-DI

Fact-level verified

A new UDI-DI is required for a change that could cause device misidentification or ambiguity in traceability. The expressly listed triggers include changes to the device name or trade name and the device version or model.

Conditions
  • First determine what the changed SMN/REF represents: an internal order number alone is not automatically a change of device model or version.
  • This concerns UDI identification; no new Basic UDI-DI, conformity certificate or approval period is automatically inferred.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

Change control →UDI, listing & traceability →Label, IFU & language →

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval
  • Supporting documents

IVDR: notified-body assessment of substantial QMS or device-range changes

Fact-level verified

The manufacturer must inform the notified body that approved its QMS of planned substantial changes to that QMS or the covered device range. The notified body assesses the proposed changes and any need for additional audits; approval takes the form of a supplement to the EU QMS certificate.

Conditions
  • Apply only to the Annex IX certified QMS/device-range route and a change that meets its substantial-change trigger.
  • A logo, office address or internal order-number edit is not classified as a substantial QMS change merely because it appears in the question.
  • The clause supplies no fixed best/expected/worst assessment time and no automatic combined-filing permission.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

  • Filing route and prior approval

IVDR: own-name supply and manufacturer obligations

Fact-level verified

A distributor, importer or other person assumes manufacturer obligations if it makes a device available under its own name, registered trade name or registered trade mark. The clause has an exception where a distributor/importer has an agreement under which the manufacturer is identified as such on the label and remains responsible for meeting the Regulation’s manufacturer requirements.

Conditions
  • Assess the actual legal actor and the Article 16(1)(a) agreement exception; do not treat every cosmetic logo change as a new legal manufacturer.
  • This is a role/responsibility rule; it does not itself establish that a certificate or registration can be transferred to another legal entity.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

  • Labels and identifiers

IVDR: manufacturer and authorised representative label identity

Fact-level verified

The label must state the manufacturer’s name, registered trade name or registered trade mark and the address of its registered place of business. For a manufacturer outside the Union, it must also state the authorised representative’s name and registered business address.

Conditions
  • This is a label-content obligation, not a standalone authority change-approval route.
  • A registered office/address change is assessed separately from a physical production-site change.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

Conditions for this question

  • Apply this manufacturer/authorised-representative identity rule only when the actual change affects the displayed manufacturer name, registered trade name/trade mark, registered address or authorised-representative details; device branding alone requires its own assessment.
  • Labels and identifiers

IVDR: name, trade name or model changes and a new UDI-DI

Fact-level verified

A new UDI-DI is required for a change that could cause device misidentification or ambiguity in traceability. The expressly listed triggers include changes to the device name or trade name and the device version or model.

Conditions
  • First determine what the changed SMN/REF represents: an internal order number alone is not automatically a change of device model or version.
  • This concerns UDI identification; no new Basic UDI-DI, conformity certificate or approval period is automatically inferred.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

  • Supporting documents
  • Labels and identifiers

IVDR: agreement for changing the authorised representative

Fact-level verified

A change of authorised representative requires an agreement between the manufacturer, the incoming representative and, where practicable, the outgoing representative. It must address the old/new mandate dates, the cutoff for indicating the outgoing representative in supplied information, transfer of documents including confidentiality/property rights, and forwarding of incident complaints after the old mandate ends.

Conditions
  • Apply only when the EU authorised representative actually changes; this is not a generic transfer of a product marketing authorisation or a change of importer.
  • The agreed date for using the outgoing representative’s information is not a universal stock-sale grace period.

Reuse of the exact archived IVDR consolidated expression current to 2025-01-10; reviewed applicability is confined to this clause. No uniform authority approval period, universal combined filing, or factory relocation is inferred.

Change control →Official forms & portals →
Regulation codes

What these codes are

Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.

Use this market context

Continue from regulations into practical research

Keep European Union as the target market while you move into registration records, classification, cross-country product research, or pathway planning.

Classify a device for European Union

Check a preliminary EU MDR risk class.

Search registered products

Inspect public EU MDR records.

Compare products across markets

Search the same product in multiple country registries.

Build a registration plan

Estimate pathway, government fees, preparation, and review time.

Build a reusable product master

Structure company, product, model, approval, and evidence facts once.

Map dossier reuse and deltas

Compare existing evidence against European Union needs.

Build a market-launch workpaper

Connect route, evidence, labels, representatives, and launch dependencies.

Assess a regulatory change

Test a current EU MDR update against one product and its evidence.

Keep researching this market

More European Union medical device resources

View the European Union resource hub →
Compare regulations across all countries →
Continue with this market
Tracked from official EU MDR publications · row IDs are stable — cite as regulations:eu:eudamed-2025