Post Market Clinical Follow up, what is this and what do I need to do?

Over the last few years there has been an increasing focus from medical device regulators on demonstrating continuing performance and safety of products after their initial product approval. Particularly in the European Union and following the EU MDR 2017/745 regulations, there is a concept of ‘Post Market Clinical Follow Up’ (PMCF) which is introduced as a general obligation for all manufacturers to perform, as part of the post market surveillance of the products they manufacture.

As a medical device quality and regulatory consultancy, we often see that manufacturers being assessed for EU MDR compliance come to us after receiving non-conformities from their EU Notified Body, requiring them to perform additional Post Market Clinical Follow Up in order to achieve their initial EU MDR certification.

The regulation defines Post Market Clinical Follow Up as a process which proactively collects and evaluates clinical data from the clinical use of a device, with the defined aim of:

1. Confirming the safety and performance throughout the expected lifetime of the device
2. Ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.

When looking at putting in place a Post Market Clinical Follow Up process for your devices, first consider the existing level of clinical evidence for a device – that is whether there is already a good level of published and analysed clinical data from completed clinical investigations, case studies and other safety data available from existing pre-market product testing and post market surveillance activities for the product. This existing data will usually be summarised in the Clinical Evaluation Report for the device.

To meet the PMCF expectations of EU regulators, we then look to what activities could be performed and considered, which can be categorised into general activities and more bespoke activities.

General activities are often less scientific or robust methods of performing PMCF, but are more cost effective for the manufacturer to perform, such as:

• Screening of scientific literature databases.
• Interviews or surveys with clinicians or patients using the product, to gather information on clinical experience, safety and performance on use of the product.
• Case studies and other reports demonstrating the device intervention and its outcome for the patients.

More bespoke activities often provide more robust, better quality clinical data, but are generally more costly activities so are usually targeted and prioritised to higher risk products, or products with less existing clinical data, such as:

• Manufacturer initiated post market clinical investigations and studies.
• Investigator initiated investigations, where a clinician or other party outside of the manufacturer initiates their own study on a device.
• Assessing information from company, national or international registries, which usually identify patients, interventions and outcomes and complications or side effects for specific product types, such as implants.

There are certain circumstances where bespoke Post Market Clinical Follow up activities can be justified as not being required, however this is a more difficult route to follow under EU MDR than historic regulatory systems and is typically appropriate only for low risk medical devices which have a known and demonstratable history of safe use, alongside a robust post market surveillance procedure and the general PMCF activities outlined above.

For each medical device or family of products, the chosen PMCF activities and methods for evaluating and reporting on the data are documented in a specific PCMF plan, which forms part of the device Post Market Surveillance plan. More detailed protocols may also be required to demonstrate how data will be specifically collected, analysed and evaluated.

When evaluating data gathered from PMCF the key principle to consider is the scientific and data analysis methodology used, to ensure it is systematic and fair taking into account both positive and negative information. As part of the data analysis, assess the new data to determine if the information demonstrates continuing safety and performance of the device, for example:

1. If there are new or changed risk types or unexpected side effects to consider.
2. If there are issues with misuse of the device, user errors, or common use outside of the approved indications and intended use.
3. If there are any device safety, performance or user concerns identified which require further monitoring or action.

The results of the PMCF activity need to be documented, usually as part of a device specific post market clinical follow up report, a section of the post market surveillance report or, as part of an update to the clinical evaluation report for the product.

If you need help in understanding the expectations of EU regulators on post market clinical follow up for your product, or want support in implementation or completion of post market clinical follow up activities for your products get in touch with IMed Consultancy and write to us at hello@imedconsultancy.com