Parminder Kalle, senior solutions delivery manager at Maetrics, provides advice for medical device manufacturers highlighting the regulatory changes occurring in Post Market Surveillance (PMS) and showing what the best practice is for manufacturers to follow to ensure they meet all compliance regulations
Recently there has been a big shake-up among medical device regulators and it is time manufacturers stepped up to the mark when it comes to ensuring they remain compliant
Recently there has been a big shake-up among medical device regulators and it is time manufacturers stepped up to the mark when it comes to ensuring they remain compliant.
Specifically, the impending publication of the Medical Device Regulation (MDR) in Europe, and the increasing attention that regulatory bodies all around the globe are placing on post market surveillance, is pushing medical device manufacturers to analyse their processes in this area to ensure they are meeting all compliance regulations.
The changes come as regulatory bodies are implementing requirements for more-pro-active post market surveillance mechanisms, rather than simply relying solely on reactive systems such as complaints monitoring.
Any manufacturer wishing to start, or maintain, distribution of their devices in markets that have specific requirements for post market surveillance, needs to review its processes and practices to ensure it is doing all the right things
Any manufacturer wishing to start, or maintain, distribution of their devices in markets that have specific requirements for post market surveillance, needs to review its processes and practices to ensure it is doing all the right things to stay compliant. In order to help manufacturers meet compliance standards, National Competent Authorities (NCAs) have been working towards clarifying the requirements for post market surveillance, as defined within the Medical Device Directives.
The existing set requirements which are being implemented by regulatory bodies in fact leave a lot of room for varying interpretations. The MDD 93/42/EEC, Annex II, for example, states that there should be commitment from the manufacturer to implement and keep up to date a systematic procedure in order to review experience gained from devices in the post-production phase. This needs to be treated as an add-on to the provisions which are referred to in Annex X – requiring manufacturers to implement appropriate means to apply any necessary corrective action and notify the competent authorities accordingly.
Then there is the MEDDEV 2.12-1, Vigilance Guidance Document, Revision 5, which outlines further that manufacturers must have efficient systems for pro-active scrutiny of trends in complaints and incidents in place. If there was to be a significant increase in incidents or events, then it is mandatory for manufacturers to provide trend reports to their NCAs. Pro-active monitoring could include focus groups, questionnaires, and company forums. However, it is important for manufacturers to remember that their company personnel - sales and customer service personnel - will also have a wealth of useful feedback as they are the ones who are in constant contact with both customers and users.
Post market surveillance is an area under intense scrutiny by many regulatory bodies and is being treated as a key activity in ensuring the early detection of device issues and in protecting patient and user safety
The requirements of post market surveillance should also be in direct proportion to the risk associated with the specific medical device. This should be based on its intended use, for example, whether the product or the technology is new to the manufacturer, the extent of available scientific knowledge and market experience with other similar products and technology. Providing incident reports to the NCAs is compulsory when a ‘serious deterioration in health’ has been caused by a medical device. However, deciphering what exactly a serious deterioration in health is can often be problematic.
Many medical device manufacturers might feel daunted by the new, more-stringent and complex post market surveillance requirements. However, it is important for manufacturers to be aware that implementing stricter rules to ensure compliance can in fact yield more advantages than they imagine. Implementing proactive methods for post market surveillance can result in the production of safer devices and subsequently provide much-improved patient/user safety. Pro-active post market surveillance means the early detection of device flaws will result in improved products resulting in fewer complaints. This means lower complaint handling and resolution costs as well as much improved reputation and customer loyalty.
Relying solely on reactive mechanisms is simply not enough and it is time manufacturers realised the importance of keeping ahead of the curve to avoid rushed last-minute solutions and periods where they are not meeting all compliance regulations
However, if manufacturers are found to have slacked on their post market surveillance practices, they risk facing big penalties. Company executives could find themselves with large fines, and some may find themselves facing hefty jail times. Other penalties could include seizure of products or the imposition of ad hoc compliance contracts.
Post market surveillance is an area under intense scrutiny by many regulatory bodies and is being treated as a key activity in ensuring the early detection of device issues and in protecting patient and user safety. Post market surveillance also helps manufacturers to spot design flaws early on. Manufacturers need to ensure that their processes keep in line with current post market surveillance requirements and that they are pro-active and keep them abreast of any impeding changes. Relying solely on reactive mechanisms is simply not enough and it is time manufacturers realised the importance of keeping ahead of the curve to avoid rushed last-minute solutions and periods where they are not meeting all compliance regulations.
