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Stricter EU Medical Devices Regulations – Does the patient win or lose?

22 Nov 17 - 12:00AM Carl Marotta  | Skills Alliance blog

EU Medical Devices Regulations – Does the patient win or lose?

What effect will the new Medical Device Regulations have on a company when seeking to improve a devices safety, will it simply become more difficult to get the device to the market? Do patients stand to gain or lose from more rigorous regulations, higher costs and less choice in the market?

A company’s operational strategy will inherently be dictated by patent expiry and regulation changes. With the new MDR’s in a transition period up until May 2020 (2022 for IVD’s), it is worthwhile discussing how much of an effect will these changes will have on the industry and ultimately patient access.

Unfortunately, as is too often the case in life, positive change doesn’t occur until something negative precedes it. In this instance, the scandal surrounding the fraudulent production of silicone breast implants by the French company PIP in 2012 highlighted the need for stricter regulations, rather than the ‘laidback’ approach taken by the notified bodies for conformity reviews for of the “old” medical device directives.

The new MDR’s were put in place to target medium to high risk devices which include Class IIa, IIb and III to ensure greater protection on patient safety moving forward. This means it will become more difficult to bring Class IIa, IIb and III devices to market in EU and put pressure on QA and regulatory affairs teams to adapt quickly. The MDR’s could also encourage a change in commercial and regulatory strategies. From a QA standpoint, the changes will force companies to invest more time and money into the maintenance of quality systems

As governing authorities place greater pressure on the notified bodies to become stricter in their conformance assessments, it is clear that this will have a knock-on effect for the manufacturing companies to improve compliance. Early planning seems key, with many of my clients already taking actions by setting new training programs for compliance, revaluating their quality systems to implement changes in a Quality By Design approach rather than historic Risk Assessment systems.

It is 3 years before the MDR becomes the EU industry standard but in the time leading up to its full implementation in 2020, organisations will have to plan in advance to ensure they are able to manage these new regulation changes that will force them into altering their operational strategies. The changes and stricter legislation will mean greater patient safety yes, but, and ultimately that is a price worth paying. The loss may be smaller companies being restricted from entering the market because of financial regulatory and quality costs. Patient safety and confidence in existing products should come ahead of patient access to potentially new products.

Roberto Esposito

Consultant - Regulatory

0207 220 6219