CLINICAL AFFAIRS under MDR
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.
The data collected will be used to update the following content:
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.
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.
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.
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.
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.
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.
If post-marketing clinical surveillance is not considered necessary, this must be justified and documented.
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.
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).
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.
Even after a medical device has been launched, it may be useful to conduct PMCF studies as part of post-market clinical follow-up (PMCF).
In this way, further clinical experience data can be collected with a medical device under everyday conditions and, if necessary, long-term effects can be better assessed. PMCF studies should always be considered if, for example, the following aspects apply:
PMCF studies are conducted with the corresponding CE-marked medical device within its intended use according to the instructions for use and according to a PMCF plan. The clinical data collected shall complement any data obtained prior to placing the medical device on the market to demonstrate conformity with regulatory requirements. If PMCF studies are not deemed necessary, this must be justified and documented.
In the case of implantable devices and class III devices for which clinical investigations have not been conducted in accordance with Article 61 (4) of the MDR, the post-market clinical follow-up plan shall include PMCF studies to confirm the safety and performance of the device.
We support you in generating, collecting and updating clinical data for the entire life cycle of your products. MEC-ABC acts as a guide, providing advice to help you understand and correctly apply all regulatory requirements.
Our experts help you with the implementation of PMS/PMCF processes, we support you in the execution of PMS/PMCF activities such as PMCF studies and prepare all necessary documents (e.g.: PMS Plan, PMS Report, PSUR, SSCP, PMCF Plan, PMCF Report).
MEC-ABC GmbH
Karmeliterstr. 10
52064 Aachen
Tel.: +49 241-51967486
Mail: info@mec-abc.de
The MDR is mandatory from 26 May 2021 after a four-year transition period.
Use our free newsletter about the certification of medical devices under MDR.
Bleiben Sie informiert!
Ihre hier eingegebenen Daten werden lediglich zur Personalisierung des Newsletters verwendet und nicht an Dritte weitergegeben. Sie können sich jederzeit aus dem Newsletter heraus abmelden oder Ihre Einwilligung jederzeit per E-Mail an info@mec-abc.de widerrufen. Ihre Daten werden nach Beendigung des Newsletter-Empfangs innerhalb von 1 Monat gelöscht, sofern der Löschung keine gesetzlichen Aufbewahrungspflichten entgegenstehen. Durch Absenden der von Ihnen eingegebenen Daten willigen Sie in die Datenverarbeitung ein und bestätigen unsere Datenschutzerklärung.
Sollte die Mail nicht in Ihrem Posteingang zu finden sein, kontrollieren Sie bitte auch Ihren Spamordner.
Bleiben Sie informiert!
Ihre hier eingegebenen Daten werden lediglich zur Personalisierung des Newsletters verwendet und nicht an Dritte weitergegeben. Sie können sich jederzeit aus dem Newsletter heraus abmelden oder Ihre Einwilligung jederzeit per E-Mail an info@mec-abc.de widerrufen. Ihre Daten werden nach Beendigung des Newsletter-Empfangs innerhalb von 1 Monat gelöscht, sofern der Löschung keine gesetzlichen Aufbewahrungspflichten entgegenstehen. Durch Absenden der von Ihnen eingegebenen Daten willigen Sie in die Datenverarbeitung ein und bestätigen unsere Datenschutzerklärung.
Sollte die Mail nicht in Ihrem Posteingang zu finden sein, kontrollieren Sie bitte auch Ihren Spamordner.
Das Template-Paket Klinische Bewertung ist für Sie jetzt zum Angebotspreis in limitierter Auflage verfügbar.
Sichern Sie sich unsere Whitepaper zu “Anforderungen der MDR” und “Übersicht über die Konformitäts-Bewertungsverfahren”.
