Regulation 2026/977: a missed opportunity!

 The episode takes a critical look at Regulation (EU) 2026/977, published on May 5, which introduces uniform and rigid timelines for the conformity assessment activities of Notified Bodies—for example, the review of the technical documentation within 90 days, with a maximum of four ‘clock stops’.” 

Transcript

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Welcome to Compliance Espresso, the podcast where we break down European medical device legislation with clarity, rigor, and just a hint of irony. Short episodes designed to give you reliable guidance in just a few minutes, like a good cup of coffee. I'm Nicola Focci. I've been working in the medical device field for over 25 years, including 8 years inside notified bodies. Let's get started. On May 5th, Regulation 2026 977 was published in the Official Journal, which, quoting its title, lays down certain uniform procedural and quality management requirements for conformity assessment activities carried out by a notified body. Many words to express an apparently simple concept, the regulation sets rigid timelines for notified bodies when carrying out their activities, harmonizing them across the board. About time, someone might say, finally, no more delays. Well, I am obviously BZ, but a notified body is a private non-state organization whose delays are almost always caused by two factors: limited internal resources and poor external responses from the manufacturer. The timelines introduced by this regulation, already opposed by notified bodies through Team MB Trade Association, are in fact only apparently generous. Let us consider the review of the technical documentation. Regulation 977 requires notified bodies to take no more than 90 days, starting from the moment the notified body initiates the assessment of the technical documentation of each device or of each representative device until the final review is completed. The regulation also allows for clock stops, that is, moments when the stopwatch is posed, where a manufacturer must address causes of non-compliance or duly justified questions and requests from the notified body that are necessary for its assessment. 90 days, presumably calendar days since the regulation does not specify, may seem like a long time. 3 months. In 3 months, a sunflower grows from a seed to taller than a person. In 3 months, the Earth travels more than 230 million kilometers around the sun and so on. However, one must also consider the state of the technical documentation submitted, which may generate many findings and therefore several rounds of corrective actions. Yes, I can stop the clock four times, but four rounds may easily not be enough. I've seen cases when even ten rounds were performed. It's clear the assessor must write findings in a clear and objective way, otherwise time is wasted. But these findings are often far from purely formal and therefore require a considerable time effort. If, at the fifth round, the client tells me they still need another three months, but I have already used up three months myself, what do we do? I would also like to point out that the upper limit of this time frame is not the end of the technical documentation assessment with all findings closed, but the review. But specify indicators such as the percentage of conformity assessment activities completed within the maximum time limits without linking them to a target, a quantified objective, seems to me rather a sterile exercise. Is 50% acceptable? 60%, 30%, does everyone decide for themselves? Then what exactly has been harmonized? In company jargon, one will say it is something done just to tick a box, the kind of thing that keeps auditor happy, but in practice serves no real purpose. I told you, I am biased, and I understand the commission intent, but I have a strong impression that once again we are facing a missed opportunity, or if you prefer, yet another patch applied to legislation, the MDR regulation, whose origins were like Swiss cheese full of holes. In any case, we will all have time to digest this regulation as it applies from 25 February 2027. Which represents yet another contradiction. If the real goal was to speed up the process, perhaps it should have been done before the end of the extension, rather than at the very last minute. But that's how it is, right? You've just listened to an episode of Compliance Espresso. The next episode will be out in two weeks. If you have comments or suggestions, feel free to write me at nicola at focci.it. Thank you for listening.