Post Market Surveillance: Beyond Pain to Unlocking Potential- New Free Whitepaper by IMed Consultancy

Oxford, UK company, IMed Consultancy has launched a free whitepaper on the theme of Post Marketing Surveillance. The company says its piece reveals “how medical device manufacturers can turn the gruelling operational effort of Post Market Surveillance (PMS) into an opportunity to maximise efficiency, protect patient safety and gain competitive advantage.” The new whitepaper is available to download free of charge here.

iMed Consultancy is a leading provider of expert services to the global medical and health technology industry internationally,

About Post Market Surveillance

Medical Device Regulations underpin all commercial activity for the MedTech sector in Europe. Search our pages to find many examples of the importance of Post Market Surveillance.

To better safeguard patient safety, regulators across the world are raising the bar on PMS. In particular, the updated requirements of new EU Medical Device Regulation 2017/745 (EU MDR) and EU In Vitro Diagnostics Regulation 2017/746 (EU IVDR) and the new PMS Statutory Instrument (SI) in the UK place a greater onus on the medical device manufacturer to perform more rigorous and extensive PMS.

Manufacturers need to provide clear and comprehensive, periodically updated, information on the safety and use of their products. This includes labelling, design, technical features, composition, packaging, and instructions for assembly. Furthermore it extends to installation, use and maintenance and can be significant in terms of “man hours” and documentation.

The Post Market Surveillance Opportunity

IMed Consultancy says companies should also see PMS as an opportunity. The new requirements should not be seen only as a box that needs to be ticked to achieve compliance. Indeed PMS can yield huge strategic business potential. Specifically, PMS is key to monitor the safety and performance of a medical device throughout lifecycle. This helps businesses avoid costly remediation and brand damage. Additionally it can support companies to achieve commercial advantage by opening up to opportunities in geographies with similar requirements, identifying new uses, user demographics and more.

Thorough, ongoing PMS that spans the entire lifecycle of the product, should help identify emerging risk early. In effect this means before it creates serious harm to patients. But it can also help identify weaknesses in design. Resulting improvements can eventually make the device far more user friendly and competitive. By gathering more extensive data companies can also substantiate claims and carry out effective performance evaluations. Furthermore they can potentially also explore new claims, thus expanding the devices’ market.

From a more operational perspective a well-planned and consistently managed, cyclical process can help achieve huge efficiencies. Take for example literature searches: these can be optimised through scheduling of PMS in close succession to Clinical Evaluation Reporting (CER) or Performance Evaluation Reporting (PER). Similarly, intelligent use of AI can support (though not replace) Expert Authors and Evaluators.

Managing Director Comments

Jonathan Ripley, Managing Director at IMed Consultancy, comments: “The evolution of PMS confirms that compliance can be a strategic opportunity. By adopting a comprehensive, cyclical approach to PMS, manufacturers can not only ensure patient safety but also streamline operations, enhance product development and explore new international markets.

“At IMed Consultancy we’ve long espoused this approach, where regulatory compliance is not just a tick of the box. Rather it’s a strategic activity that reveals new opportunities for efficiency and growth. As regulations continue to evolve, the need for meticulous documentation, proactive risk management, collaboration and transparency across the supply chain increases. It is critical that medical device manufacturers are able to embrace these changes and leverage them to help fuel innovation, reactivity and market advantage.”

published: January 28, 2025 in: Articles of interest, Regulatory

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