MDR Annex II and Annex III Explained

Annex II, Section 1: Device description and specification

• Product or trade name and a general description, including intended purpose and intended users
• Basic UDI-DI
• Intended patient population, medical conditions, indications, contraindications and warnings
• Principles of operation and mode of action
• Rationale for qualification as a medical device and the risk class, with the classification rule applied
• Novel features, variants and configurations, accessories and other products intended to be used in combination
• Description of key functional elements, raw materials and materials in contact with the body
• Technical specifications such as features, dimensions and performance attributes
• Reference to previous and similar generations of the device (Section 1.2)

Annex II, Section 2: Information supplied by the manufacturer

A complete set of the labels on the device and its packaging and the instructions for use, in the languages accepted in the Member States where the device is intended to be sold. The content requirements are in Annex I Section 23.

Annex II, Section 3: Design and manufacturing information

Information that allows the design stages to be understood, and complete information and specifications on the manufacturing processes and their validation, adjuvants, continuous monitoring and final product testing. It also identifies all sites, including suppliers and subcontractors, where design and manufacturing activities are performed.

Annex II, Section 4: General safety and performance requirements

For each GSPR: whether it applies and, if not, why; the method used to demonstrate conformity; the harmonised standards, common specifications or other solutions applied; and the precise identity of the controlled documents that provide the evidence. Most reviewers start the technical documentation review here.

Annex II, Section 5: Benefit-risk analysis and risk management

The benefit-risk analysis referred to in Annex I Sections 1 and 8, and the solutions adopted and the results of the risk management referred to in Annex I Section 3. In practice this is the risk management plan, the risk analysis and the risk management report.

Annex II, Section 6: Product verification and validation

Section 6.1 covers pre-clinical and clinical data: results of tests such as engineering, laboratory, simulated use and animal tests, and the evaluation of published literature; detailed information on test design, protocols and data analysis covering biocompatibility, physical, chemical and microbiological characterisation, electrical safety and electromagnetic compatibility, software verification and validation, stability and shelf life, and performance and safety. It also contains the clinical evaluation report, its updates and the clinical evaluation plan, and the PMCF plan and PMCF evaluation report or a justification why PMCF is not applicable.

Section 6.2 lists additional information for specific cases, including devices incorporating a medicinal substance, devices made with tissues or cells of human or animal origin, substance-based devices absorbed by the body, devices containing CMR or endocrine-disrupting substances, devices placed on the market sterile or in a defined microbiological condition, devices with a measuring function, and devices to be connected to other devices.

Annex III: Technical documentation on post-market surveillance

How MDRpilot maps these sections

Each section is part of the product's technical file in MDRpilot. Section 1 is drawn from the product record and the Annex VIII assistant, Section 2 from the IFU module and label export, Section 4 from the GSPR module, Section 5 from the ISO 14971 risk file, Section 6 from evidence files and the clinical module, and Annex III from the PMS module. Status per section shows what is still missing.