That extension is very likely to be agreed in Q1 of 2023 – providing additional time to get medical devices compliant and approved. With more time to get certification, it’s easy to forget that MDR compliance also has inherent business benefits – just as noncompliance has negative financial and reputational consequences. So in this blog post, we look at 4 important aspects of the MDR and how compliance can add value for medical device companies.

1 Mitigate Risk In Supply Chains

Unlike other commercially available products, there’s an imperative for medical devices to be reliable and function properly at all times. That’s because when a medical device does not function properly there can be significant consequences for everyone involved, including patients, medical professionals, healthcare providers, and medical device companies.

In the past, the parties involved around medical devices imported from outside the EU were not subjected to particularly stringent regulations. The incoming regulation has changed that. Under the MDR, both the importer and the European representative that acts as a placeholder for the company in Europe needs to check for product compliance before releasing it in the EU market. It’s an added responsibility to ensure compliance, so there needs to be a firm agreement between them and the manufacture regarding responsibility for the product.

Both EU and non-EU manufacturers also need to carefully consider their distributors. This is new and important because it means distributors in the EU now have responsibility for checking a product’s compliance with the MDR. For example, higher risk products should be labelled with the number of the notified body. Nonconformities – including products which have not been certified – are identified sooner, so noncompliant products can be withheld or removed from the market before they potentially endanger a patient’s life.

2 Build Credibility In Non-EU Markets

When it comes to ensuring product quality and compliance with regulatory standards, the European conformity mark – CE – has also significant value outside of Europe. Whilst it’s not a statutory requirement on other continents, it is highly regarded and a gold standard in terms of health, safety, and environmental requirements.

That’s great news for medical devices destined for markets outside of Europe. In this respect, compliance with the MDR has cross-border advantages. Obtaining the correct certification sends the right signals to other countries. In fact, many other markets around the world, such as Africa, Asia, and the Middle East, very much rely on European certification. Typically, these countries demand export licences and to see certification of conformity to agree to a device being made available in their market.

As the previous certification becomes obsolete, other global markets will start to demand conformity with the MDR. So without MDR certification, companies are in danger of losing those markets as well. That’s another reason why medical device makers need to ensure they’re fully compliant with the MDR.

3 Increase Customer Confidence

Another important aspect of the MDR is a stronger focus on the benefits of medical devices. Not only must a device be proven in terms of safety and performance – certification also requires substantiated evidence of its benefits.

Built into the MDR is the requirement for devices to be registered on the new EUDAMED database which will provide ‘a living picture of the lifecycle of medical devices that are made publicly available in the European Union’. The database contains important information about a device, including a summary of safety for higher risk devices, as well as the proven benefits. It also acts as a portal for capturing and recording complaints or any ongoing or past recalls regarding a product. EUDAMED will, when fully operational, provide a definitive overview on the safety of medical devices available in Europe.

Backed by solid clinical data, the benefits of a medical device can now be justifiably claimed by marketing and sales teams. Not only that, but both procurement and medical professionals can have greater confidence in the reliability of new products. Furthermore, the benefits of a device are now included in the instructions for use or accompanying information – which provides another valuable layer of reassurance for its users.

And that’s not all. With the need to appoint a Person Responsible for Regulatory Compliance (PRRC) – a role comparable to the Qualified Person in pharmaceutical companies – medical device companies now have a single point of contact, and clear accountability if something goes wrong.

4 Get New Devices Market-Ready

One of the overarching benefits of the MDR is that it provides a single regulation for multiple EU countries. For new medical device manufacturers, or existing companies with a new product line, the MDR is the place to be in terms of general market access. For that reason, Article 10 – the obligations for manufacturers – is of key importance.

From device classification to the specific requirements for each type of device, the MDR is a one-stop shop providing guidance on getting devices market-ready. That includes checklists of the documentation needed and full guidance on how to validate safety and performance. Having products correctly described for the MDR also benefits a company’s Quality Management Systems (QMS), and vice-versa.

Overcoming the challenges around product quality and regulatory compliance can be complex and time-consuming. That’s where Peercode Regulatory Consultancy can help. Talk to a specialist.