Newsletter No 5 July 2019
Subject: MDR preparation of the STS Medical Group, Nr.5 July 2019
The second half of 2019 has now started, and as a matter of fact only 10 months are left to the MDR go-live day. The most of the medical device manufacturers are still working intensively on the MDR preparation to make the journey successful.
The implementation plan for MDR project are also continuing at STS Medical Group with high priority and top management attention.
In this fifth release, we would like to introduce you to PMCF (Post Market Clinical Follow up) in the context of MDR.
What is the meaning of PMCF?
For many medical devices manufacturers, clinical evaluation is currently based on the equivalence principle.
As a consequence clinical data from the literature or from clinical trials with own products are often completely missing.
Therefore, MDR’s claim is to introduce the concept of continuous clinical follow-up on products introduced in the market is the logical consequence to achieve an ongoing product evaluation and transparent monitoring of each medical device.
Why does MDR focus on this?
In fact today problems or new risks become apparent only after the products have already been used for an extended period of time or in a larger number of users and patients.
In order to protect users or patients effectively, the post-market surveillance of medical devices and their interaction with clinical evaluation in MDR has been re-defined.
What does PMCF want to achieve in detail?
The clinical evaluation will in future be updated throughout the entire life cycle of the medical device using clinical data derived from post-market clinical follow-up and post-marketing surveillance.
Focusing on this concept of continuous data update and monitoring, MDR forces manufacturers to structure and maintain the collection and evaluation of clinical data regarding their own products after placing them on the market.
For a proactive clinical follow-up, the manufacturer should collect medium- or long-term performance and safety data that allows,
– to evaluate if the benefit-risk ratio is still guaranteed;
– the further evaluation of already known risks;
– by existing evidence, to identify new risks during use;
– that the clinical safety and performance can be confirmed during the expected life-time of the product;
– to identify potential off-label use and verify the intended use.
Proactive instead of reactive
A shift in paradigm of the manufacturers approach is achieved, in fact even before they are placed on the market for the first time, manufacturers must plan how to proactively collect and evaluate clinical data of their product through clinical trials and for the post-market surveillance.
The first conformity assessment, including the clinical evaluation, sets the scope for clinical follow-up;
The clinical evaluation is not static but will be continuously reviewed over time and adjusted if necessary. This should enable manufacturers to evaluate potentially existing residual risks or ambiguities and eliminate them;
It is essential that the PMCF studies, prepared in the planning, reflect the daily routine in the use of the devices as accurately as possible;
The PMCF plans and the PMCF studies contained in them will be reviewed by the Notified Body during the certification process.
More safety and quality for patients and users
Accordingly to the future MDR, more PMCF studies will have to be performed also for lower-risk medical devices.
This, of course, leads to significantly more data being available to the manufacturers in order to positively influence the safety and quality of the products for the benefit of patients and users.
This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the PMCF.
We are already today all dependent on an effective cooperation. For the MDR implementation, we require even a closer collaboration in order to ensure we all can deliver safe supply to hospitals and patients in the future.
We are confident we’ll be able to continue to supply health care competently on customized surgical procedure sets and small kits.
Let us take the opportunity to inform you that the next MDR Newsletter will be issued in September after the August holiday season.
You want to know more about specific topics? Do you have any questions or comments? Write us
CEO STS Medical Group
Corporate Director Quality Management
and Regulatory Affairs