Post-Market Surveillance of Medical Devices
Guidelines 93/42/EEC and 90/385/EEC require manufacturers of medical devices to implement post-market device monitoring programs (Post-Market Surveillance, PMS) into their quality management system, which examine the clinical efficacy and safety of their products. These Post-Market Surveillance measures are important to detect rare incidents and complications, which may only become visible under widespread and long-term use of an approved medical device.
In many cases, a structured monitoring process of clinical data in scientific literature according to pre-defined criteria is an appropriate method of Post-Market Surveillance. Published literature and, whenever possible, conference papers and proceedings are reviewed as to their relevance to the respective medical device. This literature monitoring should be performed at defined time intervals. The resulting Post-Market Surveillance data can also be used for keeping the clinical evaluation up-to-date as required by MEDDEV 2.7.1.
Post-Market Clinical Follow-up
MEDDEV defines PostMarket Clinical Follow-up (PMCF) studies as an essential part of Post-Market Surveillance. For EU MDR, these are mandatory for most devices. PMCF studies are to be carried out according to documented, proactive and well-organized methods and procedures, which are determined by an individual PMCF plan. These PMCF studies may include:
- continued follow-up of patients from clinical investigations before market approval
- new clinical investigations
- analysis of data from observational studies (e.g. registry)
- analysis of relevant retrospective data of treated patients
Based on the requirements of current regulations, MakroCare develops and implement methods for efficient Post-Market Surveillance for you, which is in accordance with Regulations and Directives:
- Consultation on Post-Market Surveillance and design of a suitable Post-Market Surveillance program.
- Design and periodic updates of a Post-Market Surveillance report, PSUR, SSCP reports for your medical devices as part of an ongoing Post-Market Surveillance program.
- Being an ISO 14155 certified company, we run full implementation of your PMCF studies from design to data collection to report writing as a full service partner
- Development of an active Post-Market Surveillance program as an appropriate alternative to clinical PMCF studies.
- Revision of your clinical evaluation based on PostMarket Surveillance data and in accordance with guidelines.
- Revision of instructions for use, patient information sheets, others based on Post-Market Surveillance data.
- Consultation on the design and management of PMCF studies.
As part of an active Post-Market Surveillance program, we provide user questionnaires and analytical methods customized specifically for your medical device. The standardized structure of these questionnaires guarantees fast and targeted data processing and evaluation, ensuring high-quality active Post-Market Surveillance.
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