Newsletter No 3 May 2019

Subject: MDR Preparations of STS Medical Group, No.3 May 2019

Dear Customer,

Let us initiate the May release of our MDR monthly newsletter informing you that starting on 06.05.2019, we have decided to combine the functions quality management and regulatory affairs under one responsibility and leadership.  Mr. Uwe Gölz, former Quality Director for the group has been appointed Corporate Director Quality Management & Regulatory Affairs.

In this third issue, we would like to introduce you:

• to the subject of PMS (Post-Market Surveillance) within the framework of MDR

and

• the required activities and changes we have to implement into the STS Medical Group organization.

What does post market surveillance mean in the context of MDR?

The main cornerstones of the new European MDR are “post-market surveillance” (from now on PMS) and “market surveillance”.  Although these terms are often used as synonym, they embed very different meanings, in fact while “market surveillance” is the responsibility of the authorities, “post-market surveillance” is the responsibility of the manufacturers. Compared to the previous regulations, the new requirements in the articles of chapter VII and in Annex III of the MDR are much more detailed.  In particular, the proactive nature of the process is emphasized.

Essential requirements of the new MDRs are:

• The definition, planning and maintenance of a PMS process;
• The proactive and continuous collection and evaluation of information on internal production and comparable competitive products (sources and procedures are described in Annex III). Based on the available collected data it has to be decided whether:
• authorities or users have to be informed;
•  recalls are required;
• product and / or process improvements are necessary (e.g. CAPA);
• the updating of the clinical evaluation;
• implementation of a reporting to the authority built up on the collected results. Reporting to be structured depending on the risk class of each products.

The role of the retailers becomes an essential part of the post-market surveillance process through the definition of “marketable provision”.  This provision now places significantly higher demands and effort on the PMS processes throughout the whole distribution chain. It becomes of the utmost importance to plan and implement an efficient process that delivers consistent and evaluable data when information is collected in the market.

Which changes result in the reporting system (vigilance)?

 A major change in the MDR is the reduction of the re-action time in case of serious event. In fact, reporting deadlines to the competent authorities will become 15 days (currently 30 days).  On the one hand, this requires manufacturers to establish an efficient feedback processes throughout the entire distribution chain. On the other hand, it can be assumed that the number of “preventive reports” or market measures like FSN or FSCA will increase significantly with the introduction of the new deadlines, as the notification, analysis and finalization of complex issues must now be done significantly faster.

The dealers will also be given more responsibility in the future such as:

• for non-compliant medical devices or in case of suspected danger, the dealer should stop the sale;
• Distributors become also responsible for reporting to the competent authority;
• In this context, dealers also have to establish their own product documentation.

Like the current Medical device directive, MDR also requires reporting any statistically significant increase in the frequency or severity of non-major occurrences or expected adverse events.

Safety Officer (MPG) and “Qualified Person” (MDR)

The role of the Safety Officer, originally a “German specific function” known as “MPG”, is copied and implemented into MDR.  However, the role of the “Qualified Person” has a much broader range of tasks, as detailed below:

• Collecting and evaluating reports on risks in medical devices;
• Coordinating necessary measures (information of the authorities, information of the users, call-backs and corrective measures);

new responsibilities have been added such as:

• The assessment of the conformity of the products before the batch release;
• The creation and periodic review / update of the technical documentation and declaration of conformity;
• The provision of the declaration of the essential safety and performance requirements of products evaluated in a clinical trial.

What is STS Medical Group doing to implement these “PMS” requirements?

As part of the MDR project at STS Medical Group, the existing processes are checked for compliance with the changed requirements and adjusted when necessary. In particular, the preparation of “PMS” plans for the corresponding product groups plays a significant role. However, existing IT solutions and market feedback processes must also be adapted to meet the more accurate data quality, consistency and efficiency requirements. This newsletter is part of our campaign to increase the sensitivity of all our business partners in relation to PMS, to bring more clarity around the MDR journey and PMS distributor responsibilities. We are already all dependent on a good cooperation and we will need even a closer collaboration in order to ensure safe supply to hospitals and patients in the future.Especially we are confident we’ll be able to continue to supply health care competently on customized surgical procedure sets and small kits.

You want to know more about specific topics?  Do you have any questions or comments?  Write us!