Peace of Mind: Why it’s Vital to Have CE MDR in Place

By: Thijs van den Hoven

Switching from the European Union’s Medical Device Directive (MDD) to the new Medical Device Regulation (MDR) can be a complex and lengthy process for manufacturers. The deadline has been extended until either 2027 or 2028, depending on the medical device risk class. Exact Medical is proud to have been an early adopter of MDR, leading the way towards safer and higher-quality medical devices.

Challenges arising from the MDR deadline extension

Since the European Parliament voted to delay the MDR transition deadline, many manufacturers have subsequently postponed their plans to make the transition. However, failure to take swift action is risky. Manufacturers must have a written contract in place with a notified body that commits to having CE MDR in place before the deadline. There are also a limited number of approved auditors, further complicating the process because it can take a long time to prove all products comply with the new regulations. Companies that fail to be proactive face an uncertain few years. They can’t be sure that they will be served by a notable body on time to meet the deadline, and they face a race against time to ensure compliance with the most rigorous of the MDR rules.

As a result of these difficulties, many medical equipment manufacturers are discontinuing products that are too difficult to make MDR-compliant. Unfortunately, this can lead to disruption and supply chain instability. Delays and shortages for companies and patients alike ought to be avoided at all costs. Exact Medical had the foresight to understand the importance of making an early transition to MDR. That is why its customers won’t suffer from any of these issues. None of Exact’s products will be discontinued, and it has already ensured complete compliance with the new CE MDR regulations!

Gain peace of mind with Exact Medical

Exact has been proactive in securing its compliance with MDR. Thanks to tireless work by the Regulatory Assurance team, Exact managed to get certified on March 18, 2022. This means clients that rely on Exact for its medical device supplies won’t have to worry about discontinued and disappearing product lines. There are so many challenges facing the healthcare industry already. Exact provides its customers with supply chain peace of mind so they can focus on what’s important—delivering excellent care to patients around the world.