This is especially true in the EU, which implemented the new Medical Device Regulation (MDR) in 2021. Replacing the previous and less stringent Medical Device Directive (MDD), the new regulation has had a significant ramification for medical device companies.

With thousands of products requiring re-certification by the deadline of May 2024, what can medical device companies do to stay compliant and keep their products on the European market?

What We Do

Compliance with the new regulations for the manufacturing and distribution of medical devices in Europe is mandatory. And it sets the bar for compliance higher than ever before.

Right now, the EU has concerns that a number of products will be pulled from the market if they don’t comply with the new rules by the deadline. But getting a product correctly certified is a complicated and time-consuming process – it can take between 6 and 9 months from end to end. And time is running out.

That’s where Peercode comes in. We support medical device companies with regulatory compliance through our comprehensive consultancy services. At the same time, we’re also an IT company with our own medical device software such as MASK-air and Atris.

We help companies ensure that their medical devices, including software, meet the latest regulatory requirements. In addition, we provide a framework to keep them continuously updated through change management, documentation, and contact with relevant authorities.

Why It’s Important

Unlike other consultants in this field, our expertise is derived from our experience of ensuring our own medical device software is certified and compliant. We’ve already been through the transition from MDD to MDR, so we fully understand what’s needed to get it right.

In fact, we’ve got a clear view of the entire product lifecycle, from development to certification, right through to marketing. That’s why we offer a unique and innate understanding of what’s needed to overcome the regulatory challenges facing medical device companies today.

Often, pharmaceutical companies are experts in medicine, but not medical devices. In this respect, they sometimes lack the correct systems for quality control and product certification. It goes without saying that failure to comply with the latest regulations will see medical devices drop out of the market. But regulatory changes in the EU mean that in many cases it’s no longer enough for products to be self-certified. They now need approval from a notified authority.

At Peercode, we use our expertise and experience to help other businesses get the certification they need for the physical products or software services they provide to the medical industry.

How It Works

Re-certification takes time; time that many companies simply don’t have, especially if they have multiple medical device products in their catalogue. So we take a tried and tested approach to preparing a robust and evidence-based dossier for their re-certification.

It starts with the clinical claim of the product, and what it should do medically to benefit a patient. For example, telemonitoring software that helps establish a patient’s condition might be an important decision-making tool for a healthcare professional. In this way, software itself becomes a ‘medical device’ alongside physical products.

Every medical device requires clear and accurate supporting documentation, good implementation of design and use requirements, and verification. There also needs to be a rigorous testing protocol, a usability survey of physicians, plus the appropriate warnings and labelling of the intended end product. All of this, and more, becomes a part of the technical dossier.

Clearly, staying compliant with the latest medical device regulations is not an easy feat, but with our quality and regulatory services and auditing and training capabilities, we can help smooth the journey to certification, or recertification, of your medical devices.

Now you know what we do and why we do it, why not find out how we can support you with your medical device compliance? Talk to one of our specialists today.

Talk to a specialist.