As a manufacturer, you must ensure the safety and performance of your product throughout the entire product lifecycle. Both safety and performance are presented in the clinical evaluation and continuously assessed through ongoing post-market surveillance – which includes Post-Market Clinical Follow-up (PMCF).The MDR significantly tightens the requirements for clinical evaluations: Where it was often sufficient in the past to base the evaluation on the equivalence principle (comparing with another product) or on literature data, manufacturers are now required in many cases to generate their own clinical data.Let's explore together how to future-proof your clinical data
What exactly are the clinical functions of your product? And where might it already be sufficient to demonstrate effectiveness with non-clinical data? Together, we'll find out quickly.
Talk to our experts today!Is the clinical evaluation complete once the product is on the market?
Not really. It is essential that you, as a manufacturer, can ensure the safety and performance of your product throughout its lifecycle. To plan appropriate Post-Market Clinical Follow-Up (PMCF) activities within Post-Market Surveillance (PMS)), you can use a variety of approaches. These include long-term patient follow-up and reviews of known risks in the literature. With this data, you can identify potential issues with your product at an early stage, address them, and continuously adapt your next-generation products to the needs of users.
Our services in the field of PMCF
To be prepared for and successful in the future not only the relevant expertise in terms of clinical evaluation and verification is necessary but also the knowledge and experience of the actual clinical functions of a device and when it might be sufficient to prove efficacy by means of non-clinical data; because in many cases in vitro experiments in a laboratory may be conducted instead of extensive clinical tests.
Our offer
We look forward to getting to know you!
Our offer
- Development of a suitable strategy to update or complement your clinical data,
- Support in creating PMCF processes, plans, and reports,
- Consulting and guidance for the successful implementation of PMCF activities,
- Support in cost-efficient collection of clinical data through user surveys (general aspects of use / general clinical data / addressing specific clinical endpoints).
We look forward to getting to know you!
Which PMCF activities can be an alternative to clinical trials?
When clinical data are required, the following approaches are often suitable alternatives to clinical trials:
- Follow-up of patients from pre-market clinical investigations,
- Observational studies (collecting data under routine conditions),
- User surveys to collect clinically relevant information,
- Retrospective evaluation of existing data from users or patients already experienced with the product,
- Appropriate monitoring of scientific literature as well as evaluations of other post-market surveillance activities (e.g., service reports, hotline calls).
Is post-market clinical follow-up (PMCF) required?
The MDR requires a continuous process of post-market clinical follow-up, i.e., the proactive collection of clinical data after the medical device has been placed on the market, in order to confirm its safety and clinical performance.These PMCF activities are defined in a PMCF Plan, which becomes part of the technical documentation and is governed through the PMS system within the quality management system (QMS). The data generated through PMCF are summarized in the PMCF Report and used to update the clinical evaluation at regular intervals. The advantage: PMCF activities are usually far less resource-intensive in organization and execution than clinical investigations that need to be conducted prior to CE marking.
Successful adaptation to the MDR: Our whitepaper series for your medical devices
Have you already adjusted your technical documentation to comply with (EU) 2017/745 (MDR)? If not, it's time to take action and ensure that the technical documentation of your medical devices meets the requirements of the MDR. Only by doing so can you guarantee the safety, quality, and effectiveness. In our whitepaper series, you will find valuable best practices for adapting your existing products to the MDR. Start directly with Part 1: "Conversion of Your Existing Products" to secure market access for your products in the EU!
(Available only in German Language)Download our whitepaper for free now.
(Available only in German Language)Download our whitepaper for free now.
