MDR Post Market Surveillance

Transcription

1 MDR Post Market Surveillance Gert Bos Executive Director & Partner A global leading medical device consultancy group

2 surveillance - SECTION 1 POST-MARKET SURVEILLANCE PMS requires for all products: Post-market surveillance system. shall plan, establish, document, implement, maintain and update a postmarket surveillance system which shall be an integral part of QMS. Page 2 Copyright Qserve Group B.V.

3 surveillance - SECTION 1 POST-MARKET SURVEILLANCE Data gathered shall be used To update the benefit risk determination and risk management, the design and manufacturing information, the instructions for use and the labelling to update the clinical evaluation to update the summary of safety and clinical performance as referred to in Article 26 for the identification of needs for preventive, corrective or field safety corrective action for the identification of possibilities to improve the usability, performance and safety of the device when relevant, to contribute to the post-market surveillance of other devices to detect and report trends The technical documentation shall be updated accordingly. Page 3 Copyright Qserve Group B.V.

4 surveillance - SECTION 1 POST-MARKET SURVEILLANCE Post Market Surveillance plan shall address: information concerning serious incidents, including information from periodic safety update reports, and field safety corrective actions, records referring to non-serious incidents and data on any undesirable side effects, information from trend reporting, relevant specialist or technical literature, databases and/or registers, information, including feedbacks and complaints, provided by users, distributors and importers, publicly available information about similar medical devices The post-market surveillance plan shall be part of the technical documentation. Page 4 Copyright Qserve Group B.V.

5 surveillance - SECTION 1 POST-MARKET SURVEILLANCE Post Market Surveillance plan shall include: Proactive and systematic process to collect any information Methods and processes to assess the collected data Indicators and threshold values for continuous reassessment of the risk benefit analysis and of the risk management methods and tools to investigate complaints or market experiences collected in the field; methods and protocols to manage the events subject to trend report methods and protocols to communicate with competent authorities, notified bodies, economic operators and users; reference to procedures w.r.t. PMS procedures to identify and initiate appropriate measures including corrective actions tools to trace and identify devices for which corrective actions might be necessary a post-market clinical follow-up plan, or a justification why a post-market clinical follow-up is not applicable. Page 5 Copyright Qserve Group B.V.

6 surveillance - SECTION 1 POST-MARKET SURVEILLANCE Post Market Surveillance report shall include: Summary of the results and conclusions of the analyses of the gathered postmarket surveillance data Rationale and description of any preventive and corrective actions taken Updated when necessary Page 6 Copyright Qserve Group B.V.

7 surveillance - SECTION 1 POST-MARKET SURVEILLANCE Periodic safety update report (class IIa, IIb and III) Per device and where relevant per category or group of devices: Summary of the results and conclusions of the analyses of the gathered postmarket surveillance data - same Rationale and description of any preventive and corrective actions taken - same Throughout the lifetime of the device concerned Conclusion of the benefit risk determination Findings of the Post Market Clinical Follow-up Report The volume of sales of devices Estimate of the population that use the device Usage frequency of the device The post-market surveillance plan shall be part of the technical documentation Page 7 Copyright Qserve Group B.V.

8 ..the practical approach Exercise 6 A global leading medical device consultancy group Page 8 Copyright Qserve Group B.V. Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing 8

9 surveillance - SECTION 2 VIGILANCE Reporting of serious incidents and field safety corrective actions In line with the current MEDDEV document Immediately, but not later than 15 days after they have become aware For serious health threat not later than 2 days In case of death or unanticipated serious deterioration in state of health not later than 10 days Trend reporting In line with the current MEDDEV document Page 9 Copyright Qserve Group B.V.

10 surveillance - SECTION 2 VIGILANCE Analysis of serious incidents and field safety corrective actions Manufacturer perform investigations, including risk assessment and FSCA CA evaluate the risks arising from incident CA evaluate the adequacy of the field safety corrective action envisaged CA may intervene in a manufacturer s investigation or initiate an independent investigation Page 10 Copyright Qserve Group B.V.

11 surveillance -SECTION 2 VIGILANCE Analysis of vigilance data CA s proactively monitor the data available in the database in order to identify trends, patterns or signals in the data that may identify new risks or safety concerns One EU database (EUDAMED?) Contains all data discussed before Accessible to CA s and own NB s The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to the electronic system Page 11 Copyright Qserve Group B.V.

12 Role of Economic Operators Article 13 & 14 - General obligations of importers & distributors Point 2.. Where the importer considers or has reason to believe that the device presents a serious risk or is falsified, he shall also inform the competent authority of the Member State in which he is established Point 7. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and., giving details, in particular, of the non-compliance and of any corrective action taken Page 12 Copyright Qserve Group B.V.

13 Role of Economic Operators Article 13 & 14 - General obligations of importers & distributors Point Importers shall cooperate with competent authorities, at their request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market Importers, upon request of a competent authority where the importer has his registered place of business, shall provide samples of the device free of charge or, where impracticable, grant access to the device Page 13 Copyright Qserve Group B.V.

14 Major difference with current Directive Continuous evaluation and improvement loop, linking to continuous reviews of risk management and annual update of public safety and performance summary, as well as clinical evaluation Your PMS data is made available to the public (EUDAMED) Control of Competent Authorities tighter Role of the economic operators is enhanced Challenge: How do you, as manufacturer, stay in the drivers seat! Page 14 Copyright Qserve Group B.V.

15 ..the practical approach Exercise 7 A global leading medical device consultancy group Page 15 Copyright Qserve Group B.V. Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing 15