Post-Market Clinical Follow-up

An effective Post-Market Clinical Follow-up (PMCF) strategy is an essential component of all PMS systems under the MDR.

Our medical doctors have the extensive clinical experience and knowledge of study design techniques required when designing an efficient and effective PMCF system.

Annex XIV Part B requires that PMCF:

  • is a continuous process that serves to update the Clinical Evaluation.
  • comprises proactive and continuous collection and evaluation of clinical data from the use of CE-marked medical devices.
  • evidences the performance of the device in normal use throughout its entire lifetime.

In order to meet the requirements in Annex XIV Part B, manufacturers must produce Real World Evidence that demonstrates device performance in real use throughout the lifetime of the device; this necessitates a different approach to planning, implementation, performance, monitoring and reporting to standard clinical trials.

The methods used to collect and analyse data must be recorded and justified in a PMCF plan. Writing this plan and other technical documents requires clinical skill, careful thought and significant expertise. We specialise in the development of Medical Device Product Registries that conform to all MDR requirements for PMCF systems and ensure the continuous collection of high quality data.

Ensuring that PMCF technical documentation is produced to the required standard is a demanding and time-consuming process that requires a high level of professional skill. Given the short time frame before full implementation of the MDR, many manufacturers may encounter difficulties in meeting the requirements in time and simply cannot afford to have their application rejected.

At Mantra Systems, we help companies comply with the EU MDR and reduce the time needed to gain product certification under the new regulatory standard.

Our services include:

  1. Designing and implementing PMCF systems that generate real world evidence in accordance with Article 61 MDR.
  2. Producing systems that collect data throughout the entire lifetime of a device while making best use of your resources.
  3. Leveraging PMCF to deliver advantages to marketing and other departments across your organisation.
  4. Minimising time spent on ethical approvals and other administrative processes.
  5. Using our clinical experience to design systems that minimise impact on key opinion leaders and clinical sites, improving data collection compliance.

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