Post-Market Surveillance (PMS)

The medical device regulation (EU) 2017/745 demands an active surveillance after market release (Post-Market Surveillance, PMS). We at novineon understand which additional requirements and documentation you have to face.

Nonetheless, it’s valuable to view PMS as more than a tiresome duty. Results from today’s PMS are the base of your clinical evaluation tomorrow, supporting the improvement of your products quality and safety. In this case PMS including PMCF are a living process, setting the course for the future.

We support you in developing a pragmatic PMS-strategy that fulfills all regulatory requirements. We create tailor made plans and reports for your product and, if necessary, also plan PMCF activities (Post-Market Clinical Follow-Up).

What’s setting us apart from others is our holistic approach. We don’t focus on the isolated PMS, instead we keep the big picture of your technical documentation in mind. Our modularly structured documents can be updated and/or integrated into each other easily and efficiently. Thereby, you safe valuable time and resources while fulfilling your PMS requirements.
Our goal is to help you ensure the optimal safety and performance of your medical device for its users and patients and fulfill your responsibilities for the MDR at the same time.

The surveillance after the market release of your medical device must be planned and documented carefully. This is required by the MDR, multiple MDCG-documents and the ISO/TR 20416. A PMS-plan is already reviewed during an audit of your quality management system by the notified bodies.

Our service includes the development of pragmatic plans for surveillance after market release of your medical devices, as well as the full examination of your PMS data and the professional creation of the necessary reports. This includes PMS reports for class I products as well as the constantly updated report regarding the safety, also known as Periodic Safety Update Report (PSUR), for the other risk class. 

• Pragmatic and compact summary of the necessary activities and methods in a single PMS plan
• Data processing and evaluation
• Creating and updating PMS reports or PSURs

Collection of your own clinical data in context of the clinical follow-up after market release (Post-Market Clinical Follow-Up, PMCF) is not only a requirement of the MDR but also presents an advantage outside the fulfillment of the requirements.

You can distance yourself from equivalent devices and create strong marketing claims, by proactive and systemic collection and assessment of your own clinical data from standard care with your device.

The way of equivalence, prior the main body of the clinical evaluation, has a lot of disadvantages under the MDR. It is “regulatory instable”, since data can change if, for example, the intended purpose of the equivalent device changes or if contraindications are added.

Collecting your own clinical data gives you the opportunity to prove your products efficacy and safety definitely, build trust with users and patients and to elevate your products from competitors. Additionally, PMCF can give you valuable insights for future developments or create the ground for an expansion of the indication.

At novineon we support you with a tailor-made PMCF strategy to continuously improve the clinical evaluation of your product and ensure its success.

• Individual concept for PMCF from a clinical user survey, up to the creation of a register or a full PMCF study.
• Creation of MDR compliant PMCF plans
• Examination of PMCF-activities