Sunday, August 29, 2021

EU MDR Technical Documentation - Part 2

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 Technical Documentation - Part 1


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.

 

We have discussed about the sections one, two & three in our previous blog EU MDR Technical Documentation - Part 1

Let’s discuss in detail about remaining sections.

 


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4. GENERAL SAFETY AND PERFORMANCE

REQUIREMENTS


The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall include:

a. The general safety and performance requirements that apply to the device and an explanation as to why others do not apply.

b. The method or methods used to demonstrate conformity with each applicable general safety and performance requirement.

c. The harmonised standards, CS or other solutions applied.

d. The precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.

 

5. BENEFIT-RISK ANALYSIS AND RISK

MANAGEMENT


The documentation shall contain information on the following:

a. The benefit-risk analysis referred to in Sections 1 and 8 of Annex I.

b. The solutions adopted and the results of the risk management referred to in Section 3 of Annex I.

 

6. PRODUCT VERIFICATION AND

VALIDATION


The documentation shall 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 this Regulation and in particular the applicable general safety and performance requirements.

 

6.1. PRE-CLINICAL AND CLINICAL DATA


The 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, regarding the pre-clinical safety of the device and its conformity with the specifications.

a. Detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular:

b. The biocompatibility of the device including the identification of all materials in direct or indirect contact with the patient or user.

Physical, chemical and microbiological characterization.

Electrical safety and electromagnetic compatibility.

Software verification and validation (describing the software design and development process and evidence of the validation of the software, as used in the finished device. This information shall typically include the summary results of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release. It shall also address all of the different hardware configurations and, where applicable, operating systems identified in the information supplied by the manufacturer).

Stability, including shelf life.

Performance and safety.

Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council ( 1 ) shall be demonstrated.

Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision. An example of such a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service.

c. The clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV.

d. The PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.


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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