Sunday, October 10, 2021

EU MDR Post Market Clinical Follow Up

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 Technical Documentation - Part 2


EU MDR General Safety and Performance Requirement


EU MDR Information on the Label


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 requirements for Post Market Clinical Follow Up.


Let’s discuss in detail about the Post Market Clinical Follow Up as per EU MDR 2017/745.



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POST MARKET CLINICAL FOLLOW UP

 

In EU MDR 2017/745, Annex XIV Part B talks about Post Market Clinical Follow up.

 

PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of Annex XIV and shall be addressed in the manufacturer's post-market surveillance plan. When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.

 

POST MARKET CLINICAL FOLLOW UP

PLAN

 

1. PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.

 

1.1 The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data as following.

 

(a) Confirming the safety and performance of the device throughout its expected lifetime.

(b) Identifying previously unknown side-effects and monitoring the identified side-effects and contraindications.

(c) Identifying and analyzing emergent risks on the basis of factual evidence.

(d) Ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I.

(e) Identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.

 

1.2 The PMCF plan shall include at least the following.

 

(a) The general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data.

(b) The specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies.

(c) A rationale for the appropriateness of the methods and procedures referred to in points (a) and (b).

(d) A reference to the relevant parts of the clinical evaluation report referred to in Section 4 and to the risk management referred to in Section 3 of Annex I.

(e) The specific objectives to be addressed by the PMCF.

(f) An evaluation of the clinical data relating to equivalent or similar devices.

(g) Reference to any relevant CS, harmonized standards when used by the manufacturer, and relevant guidance on PMCF.

(h) A detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer.

 

2. The manufacturer shall analyze the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.

 

3. The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation referred to in Article 61 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.


Now I hope you have acquired some knowledge about EU MDR 2017/745 requirements for Post Market Clinical Follow Up. 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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