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

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 Assessment Routes.

Let’s get into the topic.

POST MARKET SURVEILLANCE

The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in following articles and Annex III.

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ARTICLE 83

The article 83 talks about the Post Market Surveillance System of the manufacturer.

Data gathered by the manufacturer's post-market surveillance system shall in particular be used for following purposes.

1. To update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I.

2. To update the design and manufacturing information, the instructions for use and the labelling.

3. To update the clinical evaluation.

4. To update the summary of safety and clinical performance referred to in Article 32.

5. For the identification of needs for preventive, corrective or field safety corrective action.

6. For the identification of options to improve the usability, performance and safety of the device.

7. To contribute to the post-market surveillance of other devices.

8. To detect and report trends in accordance with Article 88.

ARTICLE 84

The Post Market Surveillance Plan shall be drawn up in accordance with Article 84.

1. The Post Market Surveillance Plan shall be drawn up in accordance with article 84 and Part A of Annex III.

ARTICLE 85

The Post Market Surveillance Report shall be drawn up in accordance with Article 85.

1. The Manufacturers of Class I Medical Device shall submit the Post Market Surveillance Report based on the results and conclusions of Post Market Surveillance Data.

ARTICLE 86

The Article 86 talks about the Periodic Safety Update Report.

The Manufacturers of Class IIa, IIb, III Medical Device shall submit the Periodic Safety Update Report based on the results of Post Market Surveillance Data which includes the following.

1. The corrective and preventive action taken.

2. The conclusion of risk-benefit analysis.

3. Volume of sales of the medical device, usage population and its characteristics and also the frequency of usage.

For Class IIa Medical Device, the PSUR shall be updated atleast two years once.

For IIb, III Medical Device, the PSUR shall be updated annually every year.

ANNEX III – TECHNICAL

DOCUMENTATION ON POST MARKET

SURVEILLANCE

(a) The post-market surveillance plan shall address the collection and utilization of available information which includes the following.

1. The information concerning serious incidents, including information from PSURs, and field safety corrective actions.

2. The records referring to non-serious incidents and data on any undesirable side-effects and information from trend reporting.

3. The relevant specialist or technical literature, databases and/or registers.

4. The information, including feedbacks and complaints, provided by users, distributors and importers.

5. The publicly available information about similar medical devices.

(b) The post-market surveillance plan shall cover the following.

1. A proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterization of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market.

2. A effective and appropriate methods and processes to assess the collected data.

3. A suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I GSPR.

4. An effective and appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field.

5. The methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period.

6. The methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users.

7. A reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86.

8. A systematic procedures to identify and initiate appropriate measures including corrective actions.

9. A effective tools to trace and identify devices for which corrective actions might be necessary.

A PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.

Now I hope you have acquired some knowledge about EU MDR 2017/745 Post Market Surveillance. 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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