{"id":5424,"date":"2019-08-13T14:59:25","date_gmt":"2019-08-13T12:59:25","guid":{"rendered":"https:\/\/mec-abc.de\/business-services\/post-market-clinical-follow-up\/"},"modified":"2026-02-17T17:12:04","modified_gmt":"2026-02-17T16:12:04","slug":"post-market-clinical-follow-up","status":"publish","type":"page","link":"https:\/\/mec-abc.de\/en\/business-services\/post-market-clinical-follow-up\/","title":{"rendered":"Post Market Clinical Follow-Up"},"content":{"rendered":"\t\t
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Post-Market Surveillance
Post Market Clinical Follow-Up (PMCF)<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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CLINICAL AFFAIRS under MDR<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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If there’s not enough clinical data for the clinical evaluation of a medical device, you’ll need to collect your own clinical data as part of a clinical trial of that medical device.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Post-Market Surveillance (PMS)\u200b<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Medical device manufacturers are required to plan, establish, document, apply, maintain and update a post-market surveillance (PMS) system for each device. This system is part of the quality management system and should be appropriate for the risk class of the product. Post-market surveillance is used to actively and systematically collect pertinent data on the quality, performance and safety of a product throughout its life in order to derive any corrective and preventive action (CAPA) that may be necessary, to inform authorities or users, or to initiate recalls. Not all risks can be identified during the conformity assessment or approval of a medical device and only become apparent in the course of use.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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The data collected will be used to update the following content:<\/p>\t\t\t\t<\/div>\n\t\t\t\t

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  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tRisk-benefit assessment & risk management improvement (according to MDR Annex I, Chapter I)<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
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    The conclusions drawn from the analysis of the data shall lead to the identification of the need for any necessary preventive, corrective or safety corrective action. If these measures are necessary, the manufacturer takes the appropriate action and informs the competent authorities and, if applicable, the Notified Body. In addition, the data collected may be used to improve the usability “usability engineering”, performance and safety of the product and, in accordance with Article 88, to identify and report trends. Through continuous and systematic post-market surveillance, manufacturers can ensure safe medical devices and that no unmanageable risks exist.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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    Post-Market Surveillance Plan, PMS-Plan<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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    The manufacturer shall provide evidence in the post-market surveillance plan that he fulfills the obligation under Article 83 of the MDR. According to Articles 81 to 86, a manufacturer must prepare technical documentation on its PMS activities. This includes, among other things, the PMS plan, the post-market surveillance report under Article 85, and the safety report under Article 86. Annex III of the MDR describes all requirements for the technical documentation on post-market surveillance, including requirements for the collection and use of available information and requirements for the content of the PMS plan.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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    Post-marketing surveillance report<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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    The post-market surveillance report shall be prepared for Class I devices with a summary of the results and conclusions of the analysis of the post-market surveillance data collected, together with a justification and description of any preventive and corrective actions. Updates shall be made as necessary and shall be made available to the competent authority upon request.<\/p>

    Manufacturers of Class IIa, IIb, and III devices shall prepare a “safety report” that includes the following additional information compared to the “post-market surveillance report”: Conclusions from the benefit-risk assessment, major findings from the assessment report (PMCF), total sales volume of the device, estimate of the number and other characteristics of persons to whom the device in question is applied, and frequency of device use (if practicable). The safety report should be part of the product’s technical documentation. An update should be provided every 2 years for Class IIa devices and annually for Class IIb and III devices. Manufacturers of Class III or implantable devices submit the safety reports to the Notified Body.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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    Klinische \u00dcberwachung nach dem Inverkehrbringen (Post-Market Clinical Follow-Up, PMCF)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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    The European Medical Device Regulation (MDR) 2017\/745, which replaced the Medical Device Directive (93\/42\/EEC, MDD) and the Implantable Medical Device Directive (90\/385\/EEC, AIMDD) on May 26, 2021, like the MEDDEV 2.7\/1 Revision 4 Directive, requires proactive generation of clinical data as part of the Post-Market Clinical Follow-Up (PMCF) process to continuously update the clinical evaluation in accordance with Article 61 and Annex XIV, Part A. The PMCF is an ongoing process of clinical evaluation. Within this ongoing process, the manufacturer collects and evaluates clinical data from the use of the approved device to confirm safety and performance throughout the life of the device. The collection of clinical data is proactive. PMCF activities serve to identify new risks at an early stage and implement appropriate countermeasures, to monitor for previously unknown side effects and contraindications, and to continuously ensure an acceptable risk-benefit balance of the medical device under evaluation.<\/p>

    Evaluation of clinical experience data collected during clinical follow-up may be generated based on the following sources: internal vigilance system, external database research, and Post-Market Clinical Follow-Up (PMCF) studies. PMCF studies are necessary when “normal market surveillance” does not provide sufficient clinical data and clinical data are needed to update the medical device. An internal vigilance system is a market surveillance and reporting system that includes the observation and evaluation of all incidents of a medical device on the market. Manufacturers must report any serious incident and field safety corrective actions to the appropriate authorities. The time limit for notification depends on the seriousness of the incident. Upon notification, the manufacturer is required to immediately conduct an investigation of the serious incident. The following internal data can be used for the internal vigilance system, for example: User feedback, customer surveys (“Surveys”), evaluation of experiences with comparable products, maintenance and service reports, internal tests, failure analyses, as well as customer complaints and warranty claims.<\/p>

    If post-marketing clinical surveillance is not considered necessary, this must be justified and documented.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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    Post-marketing clinical surveillance plan (PMCF plan)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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    The manufacturer must define the methods and procedures for the proactive collection of clinical data as part of the clinical follow-up of a CE-marked medical device placed on the market within its intended purpose in a post-market clinical follow-up plan (PMCF plan). This must enable the manufacturer to confirm the safety and performance of the device throughout its lifetime. Side effects and contraindications must be identified and monitored, and emerging risks must be identified and investigated.<\/p>

    The justifiability of the risk-benefit balance as defined in Annex I of the MDR must be taken into account by the measures defined in the PMCF plan. Furthermore, all specific objectives of the measures to be covered by their implementation should be presented and defined in a sufficiently justified timetable. In addition to the evaluation of clinical data of the own product, an evaluation of clinical data of the same and similar products is foreseen in order to draw conclusions on the safety and performance of the own product. The PMCF plan should reference relevant parts of clinical evaluation and risk management, as well as relevant common specifications, standards and guidelines. The PMCF plan is part of the post-market surveillance plan (PMS plan) and the clinical development plan, and thus also of the clinical evaluation plan (CEP).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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    Clinical Follow-up Evaluation Report (PMCF Report)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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    The manufacturer shall analyze the results of the clinical follow-up in a Post-Market Clinical Follow-Up (PMCF) Report, which shall be part of and used to update the clinical evaluation report and the technical documentation. The conclusions of the PMCF Report shall be taken into account in the clinical evaluation according to Article 61 and Part A of Annex XIV “Clinical evaluation and post-market clinical follow-up”, as well as in the risk management according to Annex I “General requirements” Section 3.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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    PMCF-Studies<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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    PMCF-Studien werden mit dem entsprechendem CE-gekennzeichneten Medizinprodukt innerhalb seines Verwendungszwecks gem\u00e4\u00df der Gebrauchsanweisung und nach einem PMCF-Plan durchgef\u00fchrt. Die gesammelten klinischen Daten erg\u00e4nzen alle Daten, die vor Inverkehrbringung des Medizinproduktes zum Nachweis der Konformit\u00e4t mit den regulatorischen Anforderungen gewonnen wurden. Wenn PMCF-Studien f\u00fcr nicht erforderlich gehalten werden, muss dies begr\u00fcndet und dokumentiert werden.<\/p>

    Im Falle von implantierbaren Produkten und Produkten der Klasse III, bei denen keine klinischen Pr\u00fcfungen gem\u00e4\u00df Artikel 61 (4) der MDR durchgef\u00fchrt wurden, muss der Plan f\u00fcr die klinische Nachbeobachtung nach dem Inverkehrbringen PMCF-Studien zur Best\u00e4tigung der Sicherheit und Leistung des Produktes enthalten.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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