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MDR Annexes — all 17

Regulatory basis

Annexes I–XVII of Regulation (EU) 2017/745 (MDR). The annexes contain the detailed technical, procedural, and administrative requirements that implement the principles set out in the articles.

Disclaimer

This page provides summaries for navigation. Always consult the full official text for compliance purposes.

Annex I — General Safety and Performance Requirements (GSPR)​

The foundational technical requirements every device must meet. Three chapters:

  • Chapter I (§1–5): General requirements — safety, risk management, performance, state of the art
  • Chapter II (§6–22): Design and manufacture — biocompatibility, sterility, software, EMC, active devices
  • Chapter III (§23): Information supplied — labelling, IFU, symbols

Cross-referenced throughout technical documentation. Every GSPR must be addressed in the GSPR cross-reference table.

→ See GSPR overview

Annex II — Technical documentation​

Defines the structure and content of pre-market technical documentation. Six sections:

  1. Device description and specification (including intended purpose, variants, accessories)
  2. Information to be supplied by the manufacturer (labelling, IFU)
  3. Design and manufacturing information
  4. GSPR — compliance methods
  5. Benefit-risk analysis and risk management
  6. Verification and validation data (including clinical evaluation report)

→ See Technical documentation overview

Annex III — Technical documentation on post-market surveillance​

Defines the post-market technical documentation:

  1. PMS plan
  2. PSUR (for Class IIb implantable, III) or PMS report (for Class I, IIa, non-implantable IIb)
  3. PMCF plan and PMCF evaluation report

→ See Post-market data in technical documentation

Annex IV — EU Declaration of Conformity​

Specifies the mandatory content of the EU Declaration of Conformity, including device identification, regulatory basis, NB details, and signatory information.

→ See EU Declaration of Conformity

Annex V — CE marking​

Specifies the format, dimensions, and requirements for the CE marking symbol. Minimum height 5mm. Proportions must be maintained if scaled. NB identification number follows the CE mark where NB was involved.

Annex VI — Information to be submitted to EUDAMED​

Two parts:

  • Part A: Information on economic operator registration (SRN data)
  • Part B: UDI-DI information — data elements required when registering a device in EUDAMED
  • Part C: UDI-PI information — production identifier elements

→ See EUDAMED device registration

Annex VII — Requirements for notified bodies​

Detailed requirements that an organisation must meet to be designated as a notified body, including:

  • Organisational structure and independence
  • Quality management system for the NB itself
  • Resource requirements — technical experts by device category
  • Procedures for assessment, certification, and surveillance
  • Subcontracting rules
  • Record-keeping and confidentiality

→ See What notified bodies do

Annex VIII — Classification rules​

All 22 classification rules organised by device type:

  • Rules 1–4: Non-invasive devices
  • Rules 5–8: Invasive devices
  • Rules 9–13: Active devices
  • Rules 14–22: Special rules (drug combinations, tissue-derived, nanomaterials, software, radiation)

→ See Classification rules 1–22

Annex IX — Conformity assessment based on QMS and technical documentation​

The most widely used conformity assessment route for Class IIa, IIb, and III devices. Three sections:

  • Section 1: QMS assessment — scope, initial audit, surveillance audits, unannounced audits
  • Section 2: Technical documentation assessment — sampling by class; full assessment for Class III
  • Section 3: Batch release verification for certain devices
  • Section 5: Clinical evaluation consultation procedure (Art. 54) for Class III

→ See Annex IX — QMS + Tech Doc

Annex X — Conformity assessment based on EU type examination​

The type examination procedure: NB examines and tests a representative specimen of the device. Issues an EU type examination certificate. Used in combination with Annex XI. Not available for Class III.

→ See Annex X — Type examination

Annex XI — Conformity assessment based on product conformity verification​

Two parts:

  • Part A: Quality assurance of production — NB assesses the manufacturing QMS
  • Part B: Product verification — NB examines and tests a statistical sample of products from each batch

Used in combination with Annex X. Not available for Class III.

→ See Annex X — Type examination

Annex XII — Certificates issued by notified bodies​

Specifies the required content of EU certificates:

  • General certificate requirements (all types)
  • Annex IX QMS certificate content
  • Annex IX supplement (for technical documentation review)
  • Annex X EU type examination certificate
  • Annex XI Part A production quality assurance certificate
  • Validity period: maximum 5 years; renewable

Annex XIII — Procedure for custom-made devices​

Documentation requirements for custom-made device manufacturers. Requires a written statement for each device (or class of devices) including:

  • Patient identification (anonymised)
  • Prescriber identification
  • Specific characteristics of the device
  • Declaration that the device meets applicable GSPR

→ See Custom-made devices

Annex XIV — Clinical evaluation and post-market clinical follow-up​

Two parts:

  • Part A: Clinical evaluation — stages of the clinical evaluation process; literature search methodology; requirements for clinical investigations as part of evaluation
  • Part B: Post-Market Clinical Follow-up (PMCF) — PMCF plan requirements; PMCF evaluation report requirements

→ See Clinical evaluation overview

Annex XV — Clinical investigations​

Detailed requirements for clinical investigations conducted in the EU:

  • Section 1: General requirements for all clinical investigations
  • Section 2: Documentation for sponsor and investigator
  • Section 3: Obligations during clinical investigations
  • Section 4: Other clinical investigations (PMCF investigations)

→ See Clinical investigations

Annex XVI — Groups of products without an intended medical purpose​

Lists six categories of non-medical-purpose products that are nonetheless regulated as medical devices under MDR:

  1. Contact lenses (non-corrective)
  2. Products introduced into the body for cosmetic or aesthetic purposes (dermal fillers)
  3. Equipment to reduce, remove, or destroy adipose tissue (lipolysis equipment)
  4. High-intensity electromagnetic radiation equipment (lasers, IPL for skin resurfacing)
  5. Brain stimulation equipment (non-therapeutic transcranial)
  6. Equipment emitting ionising radiation for cosmetic use

Common Specifications must be published before each category becomes fully enforceable.

→ See What is a medical device?

Annex XVII — Correlation table​

Maps articles and provisions of MDD (93/42/EEC) and AIMDD (90/385/EEC) to corresponding MDR provisions. Useful for manufacturers transitioning from MDD documentation.

Official references​

ReferenceDescription
MDR 2017/745, Annexes I–XVIIFull annex texts
EUR-Lex consolidated MDRCurrent version including all amendments