Technical Documentation as per Annex II

Documentation for Medical Device as per EU MDR 2017/745

Before a medical device can be placed on the European Union market, the manufacturer must establish and document its conformity with the applicable requirements of Regulation (EU) 2017/745 on medical devices (MDR).

Comprehensive technical documentation demonstrates the device's conformity with applicable General Safety and Performance Requirements (GSPRs), supports conformity assessment by Notified Bodies and regulatory authorities, and ensures traceability throughout the product lifecycle. It includes documented evidence relating to device design, manufacturing, risk management, clinical evaluation, verification and validation, labelling, and post-market surveillance.

Important sections to be included in the technical documentation

• Device Description and Specification:

Product/accessories description, novel features, Basic UDI-DI, risk classification, and predicate information.

The intended purpose, intended users, and patient population should also be added as well as the rationale for the Qualification of the Product as a Medical Device.

The Principles of Operation of the Device and the Mode of Action supported by scientific evidence should also be included.

If the device has any novel features, it is expected that a detailed description of the novel features will be included.

The Device Risk Class and Classification Rule Justification should be documented. If multiple classification rules apply, identify all and apply the strictest rules resulting in higher classification.

Also, raw materials, critical coatings for device safety and performance, and the nature of contact with the human body (direct or indirect) should be identified, including raw materials used in primary and secondary packaging.

• Information Supplied by the Manufacturer:

Indicates that the technical documentation must include the information that accompanies medical devices when supplied to the end-user (i.e., the labels and IFU).

For the EU market, it is important to note that these documents that accompany your medical device must be provided in the languages accepted in the Member States where the device is being sold. MDR/IVDR Language requirements

• Design and Manufacturing Information:

Details device design input and output stages, its manufacturing process and flowchart, and a list of manufacturing sites and critical subcontractors / supplier. It is important that the process used to manufacture the device is clearly outlined and validated. The design requirements need to be clearly defined and the final version document controlled.

• General Safety and Performance Requirements (GSPR): Preparation and review of the Annex I GSPR checklist, including applicability assessments, conformity demonstration methods, supporting evidence references, and justifications for non-applicable requirements.
• Risk Management and Benefit-Risk Analysis: Development and review of risk management documentation covering hazard identification, risk evaluation, risk control, residual risk assessment, control effectiveness, and overall benefit-risk determination.
• Product Verification and Validation: Result of Test (Engineering, laboratory, simulated, animal) & Acceptance Criteria, with method (standard literature) as per Intended use Detailed information of design & complete test (study protocol, data analysis, data summary and test conclusion for:
• Biocompatibility (ISO 10993 Series)
• Physical, chemical (Material Standard, Carcinogenic Mutagenic Reprotoxic (CMR) & Endocrine Disrupting) & microbiological (Sterility, Bacterial Endotoxin Testing, Bioburden) Properties
• Electrical safety (IEC 60601-1) and Electromagnetic compatibility (IEC 60601-1-2)
• Software Validation (IEC 62304)
• Stability and Shel-life (ASTM F1980, Real/Accelerated)
• Performance and Safety (Product Specific Standard)
• Clinical Evaluation Report (MEDDEV 2.7.1 R-4) & Plan as per Annex XVI & Article 61
• PMCF Plan & Report as per Annex XIV /Justification

Documentation for IVD as per EU IVDR 2017/746

Before an in vitro diagnostic (IVD) medical device can be placed on the European Union market, the manufacturer must establish and document its conformity with the applicable provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

A properly structured technical documentation enables manufacturers to establish the conformity of their devices, supports the assessment activities of Notified Bodies and regulatory authorities, and provides traceable evidence throughout the product lifecycle. It brings together information relating to device design, manufacturing, risk management, performance evaluation, labelling, and post-market activities.

Important sections to be included in the technical documentation

• Device Description and Specification: Preparation and review of device descriptions covering intended purpose, scientific principles, analytes, specimen types, intended users, target populations, classification, variants, accessories, and technical specifications.
• Information Supplied by the Manufacturer: Development and review of product labels, packaging information, and Instructions for Use (IFU), including operating procedures, specimen handling, storage conditions, warnings, limitations, and interpretation of results.
• Design and Manufacturing Information: Documentation of design and development, manufacturing processes, raw materials, critical components, process controls, outsourced activities, inspections, and product acceptance criteria.
• General Safety and Performance Requirements (GSPR): Preparation and review of the Annex I GSPR checklist, including applicability assessments, conformity demonstration methods, supporting evidence references, and justifications for non-applicable requirements.
• Risk Management and Benefit-Risk Analysis: Development and review of risk management documentation covering hazard identification, risk evaluation, risk control, residual risk assessment, control effectiveness, and overall benefit-risk determination.
• Product Verification and Validation: Information on Analytical Performance of the Device, Information on Clinical Performance and Clinical Evidence, Stability (Excluding Specimen Stability), Software Verification and Validation, Additional Information Required in Specific Cases: Devices Placed on the Market in a Sterile or Defined Microbiological Condition, Devices Containing Tissues, Cells, and Substances of Animal, Human, or Microbial Origin, Devices Placed on the Market with a Measuring Function and Devices Intended to Be Connected to Other Equipment.