From a management perspective, the combination of a distant deadline and the current economic downturn, further diminishes the appeal of allocating resources to quality and compliance today. So what can those individuals with quality and regulatory responsibility do to persuade management of the business benefits?

Supply And Demand

Firstly, it’s important to understand the wider competitive landscape of medical devices destined for the EU market. According to an EU survey of Notified Bodies, there are over 17,000 medical device MDD certificates (set to expire in 2024). As of October 2022, 1,990 MDR certificates were issued and 8,000 applications were processed. The conclusion? The majority of medical devices still need to start the process of MDR certification. When you consider that there are fewer than 40 Notified Bodies, this points to two things: a bottleneck of applications, and a backlog in processing certifications.

Not only that, but 82% of QMS and product applications take between 13 and 24 months to get certified – a serious added time cost. For this reason, business leaders need to know that the race is on to stay ahead of the pack and prepare the right documentation ahead of the deadline. As a customer, which product are you more likely to trust and buy? The one with outdated certification or the one with the new certification?

CE Mark Benefits

Secondly, getting the CE mark might be a regulatory requirement, but it also carries inherent business benefits and competitive advantages. It goes without saying that for medical device companies destined for Europe, earning the CE mark gives them the right to enter that market. Not having it is a violation of the law, which can incur serious fines.

Look at it this way. The CE mark is like a passport that opens up the entire European marketplace: it allows medical device makers to freely circulate their products in the 30 countries within the European Economic Area (EEA). Another great thing is that when it comes to designing and manufacturing a product for the entire EEA, there’s only one set of requirements and procedures to comply with. Multiple – and often conflicting – national regulations are eliminated. As a result, a medical device’s documentation no longer needs to be adapted to the specific requirements of different EEA member states.

The stringent requirements of MDR certification also help to create positive perceptions of a product in healthcare professionals and patients. That’s because certification requires documentation that proves the positive impact of a device on either a medical condition or a medical professional’s ability to perform their duties. On top of that, another benefit of being MDR-certified is quality control. By implementing the requirements, the product is almost certainly safer for the user. For that reason, it’s likely to reduce claims for damage and liability.

Of course, one of the major benefits of MDR certification is wider market access. Medical devices with the European seal of approval are held in high esteem in multiple countries around the world. In some non-EU markets, certification is also taken as the regulatory standard. Put simply, many non-European countries welcome MDR-certified products. And for medical device companies, that means easier access to non-EU markets.

Risk Management

Thirdly, no medical device company wants negative press or worse still, a public lawsuit. Bringing a medical device to the European market without proper certification – according to the Medical Device Regulation (MDR) – can result in serious consequences for the manufacturer.

Not only are there financial penalties, with the manufacturer being fined for non-compliance with the MDR, but they may also be subject to legal action by regulatory authorities or affected parties. Either way, non-compliance can lead to reputational damage, from which it’s hard to recover. Alongside damage to the manufacturer's reputation, when a device is withdrawn from the market or recalled due to non-compliance, there are financial losses to contend with as well.

The other danger is that should a medical device company ride out one particular storm, there’s then the real possibility of a negative impact on future market clearance. In other words, a history of non-compliance with regulations can create a barrier to future market entry. That’s why it’s essential for medical device manufacturers to ensure that their products are properly certified and comply with all relevant regulations before bringing them to market.

Talk To A Specialist

There’s no doubt that ever-changing regulations and standards require additional effort on the part of medical device companies to stay compliant. To get everyone onboard and willing to invest the resources needed, it can be useful to bring in a specialist from outside.

A presentation or training session from an external expert on the requirements of the MDR can help you convince management of the importance to update a product’s technical file or system sooner rather than later.

Ultimately, the short-term cost of getting products MDR-compliant is much lower than the price paid later down the line, when a product is found to be noncompliant or there’s a serious incident that results in patient harm.

Ready to invest in getting a medical device MDR-certified before the deadline? Speak to an expert.