The vote of the ENVI committee to the Medical Device Regulation proposal has been postponed until September. Given the Council’s focus on notified body oversight and the process for clinical investigations, however, I do not anticipate many changes regarding the proposed requirements for postmarket surveillance, and it is worthwhile to see what is coming at you in that respect. So, what is in the proposed MDR regarding postmarket surveillance, and what clinical follow-up tools do you have to address it?
A presentation on this topic you can download here. In short:
Stricter adverse event reporting requirements
Postmarket surveillance typically is about safety with long term and wide spread use of your device, and therefore mainly concerns adverse events or incidents. More specifically whether the captured events need reporting to the Competent Authorities.
Reportable adverse events under the current MDD concern unanticipated serious adverse device effects with various reporting timelines ranging from 2–30 days. The actual reporting requirements depending on the severity of event and the implementation of the directive in local law. Under the proposed MDR all serious adverse device effects will need reporting with 15 days with an identical approach for all EU countries.
Closer monitoring of PostMarket Clinical Follow-up
Like with the current MDD since the March 2010 revision, a postmarket surveillance plan is required under the proposed MDR. This postmarket surveillance plan shall include a Postmarket Clinical Follow-up plan, and ensure updating of the clinical evaluation accordingly:
“Post-market clinical follow-up, hereinafter: PMCF, is a continuous process to update the clinical evaluation referred to in Article 49 and Part A of this Annex and shall be part of the manufacturer’s post-market surveillance plan. To this end, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which is authorised to bear the CE marking, within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence.”
Given Council’s attention to notified bodies, it is also worthwhile to note that notified bodies need to verify compliance with the postmarket surveillance plans minimally on a yearly basis:
“The notified body shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer applies the approved quality management system and the post-market surveillance plan.”
Objective of a proactive PMCF program is to capture any serious device issues before they affect patient health and safety on a scale such as with the hip and breast implants. A solid PMCF program, however, typically is time-consuming and expensive, and therefore the options in that respect need careful weighing upfront. Options include but are not limited to the following:
1. Vigilance: Using the standard company process for collecting and evaluating product complaints. The least expensive, but also the least pro-active option, that tends to find only big issues late in the game.
2. Literature review: On regular intervals collecting, reviewing and summarizing literature about safety and performance on your and/ or similar devices. Medium expensive and, provided data are published, this will give you a bigger picture than just critical issues as compared to complaint handling. Again, however, this is a reactive approach and you will find data late in the game when already made public, or data may be scarce and/ or heterogeneous.
3. PMCF Studies: Prospectively collecting, analysing, and reporting on clinical data regarding safety and performance. Options ranging from basic non-interventional registries to more complex interventional studies such as Randomized Clinical Trials (RCT). The investment will increase depending on the design of the study. Such study, however, is the only pro-active approach and when well chosen and set-up can also provide you with additional data on efficacy and/ or cost-effectiveness. A topic I previously addressed in another blog and will expand on in the future.
Under the proposed MDR reporting requirements towards the Competent Authorities will be more stringent, and there will be more attention to PMCF. Several options exist to address PMCF needs, but the investment can be substantial and careful weighing is needed to select the most cost-beneficial one for your device. Referring to the title of my blog, postmarket surveillance in its basis is simple, but as usual the devil is in the details and the choice for the right PMCF program depends on many factors, the risk class of the device being one of them.
Please do not hesitate to contact me should you be interested to discuss anything regarding the above.