Annex II EU MDR

 

 

EU MDR Annex II

 

The Annex II of Medical Devices Regulation [MDR] (EU) 2017/745 highlights all the aspects related to Technical Documentation of a medical device. This annexure could be considered as one of the main guides for a medical device manufacturer focusing on compliance with EU MDR.

 

The Annexure covers

• 1. Device description and specification, including variants and accessories
• 1.1. Device description and specification
• 1.2. Reference to previous and similar generations of the device
• 2. Information to be supplied by the manufacturer
• 3. Design and manufacturing information
• 4. General safety and performance requirements
• 5. Benefit-risk analysis and risk management
• 6. Product verification and validation
• 6.1.  Pre-clinical and clinical data
• 6.2.  Additional information required in specific cases

As a Manufacturer, here's a list of important things to keep in mind

• Technical documentation is required for medical devices to demonstrate compliance with EU regulations.
• The technical documentation must be presented in a clear, organised, readily searchable, and unambiguous manner.
• The documentation must include a device description and specification, reference to previous and similar generations of the device, information supplied by the manufacturer, design and manufacturing information, general safety and performance requirements, benefit-risk analysis and risk management, and product verification and validation.
• The technical documentation must contain detailed information on the intended patient population, medical conditions to be diagnosed, treated and/or monitored, and other considerations such as patient selection criteria, indications, contra-indications, and warnings.
• The documentation must also contain information on the method or methods used to demonstrate conformity with each applicable general safety and performance requirement, the harmonised standards, and the precise identity of the controlled documents offering evidence of conformity with each harmonised standard or other method applied to demonstrate conformity with the general safety and performance requirements.
• The documentation must include a description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body.
• The documentation must contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of the regulation.
• Pre-clinical and clinical data must be provided, including results of tests such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose or to similar devices.

It is important to consider that although Annex II states that Technical Documentation must be presented in a clear, organised, readily searchable and unambiguous manner, it provides no guidance on layout, format or structure. This has led each EU MDR designated Notified Body to issue their own guidance. In a recent publication, Notified Bodies highlighted that majority of the  conformity submissions are rejected because of:

• Incomplete Submissions – Insufficient or missing information not provided that is required for the conformity assessment activities. This includes an incomplete or inconsistent description of devices covered by the application and the related Technical Documentation (variants, accessories, combined devices covered by the Basic UDI-DI to be assessed).
• Lack of Cohesive Structure of Technical Documentation - The information is presented within the Technical Documentation but is difficult to locate.

The above has led Team NB to issue the position paper “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745” with the aim of developing a unified approach on the expectations of technical documentation submissions from manufacturers.

 

Any delay in certification can affect your market entry and sales plan. Experts suggest that Medical Device Manufacturers must focus on providing a 360 degree view of their devices through effective and efficient documentation.

We are here to present end-to-end support by creating a submission strategy, creating the technical documentation, liaising with the notified body and completing all the RAQA requirements for your devices!

 

Feel free to drop us an email – mdd@mddltd.com or fill out an interest form - https://mailchi.mp/686b393380fc/bvmauwj29a

 

We are here to be your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!

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