Tuesday, August 10, 2021

EU MDR Technical Documentation - Part 1

 Hi friends!!!


In our previous blog, we have discussed about the following topics.


EU MDR Assessment Routes


EU MDR Timeline, Annex, Chapter


EU MDR Post Market Surveillance


EU MDR Clinical Evaluation


EU MDR 2017/745 is live now. And it the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe. 


Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 Technical Documentation.


Let’s discuss in detail about Technical Documentation.


TECHNICAL DOCUMENTATION


In EU MDR 2017/745, the Annex II explains about Technical Documentation. The Technical Documentation structure in EU MDR 2017/745 has following six sections.

 

1. Device description and specification, including variants and accessories

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.

 

Let’s discuss in detail about each section.

 


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1. DEVICE DESCRIPTION AND SPECIFICATION,

INCLUDING VARIANTS AND ACCESSORIES

 

1.1. Device description and specification

 

The product or trade name and a general description of the device including its intended purpose and intended users.

The Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question.

The intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings.

The principles of operation of the device and its mode of action, scientifically demonstrated if necessary.

The rationale for the qualification of the product as a device.

The risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII.

An explanation of any novel features.

A description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with the device.

A description or complete list of the various configurations/variants of the device that are intended to be made available on the market.

A general description of the key functional elements, e.g. its parts/components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition. Where appropriate, this shall include labelled pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key parts/components, including sufficient explanation to understand the drawings and diagrams.

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, e.g., during extracorporeal circulation of body fluids

The technical specifications, such as features, dimensions and performance attributes, of the device and any variants/configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications.

 

1.2. Reference to previous and similar generations of the device

 

An overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist.

An overview of identified similar devices available on the Union or international markets, where such devices exist.

 

2. INFORMATION TO BE SUPPLIED BY THE

MANUFACTURER

 

The label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold.

The instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.

 

3. DESIGN AND MANUFACTURING INFORMATION

 

Information to allow the design stages applied to the device to be understood.

Complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the technical documentation.

Identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed.


Let's continue with remaining sections in our next blog.


Now I hope you have acquired some knowledge about EU MDR 2017/745 Technical Documentation. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.


NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


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