It’s been a long time coming, but changes to the legal framework governing the manufacturing and distribution of medical devices will soon take effect in the EU. The message to device manufacturers? Ensure your products are compliant, or see them taken off the market.

With that in mind, we’ve put together a short guide on what medical device manufacturers operating in the European market need to know about the MDR, and how they can stay compliant with the new regulations.

About MDR

Medical Device Regulation (MDR) became applicable to medical devices available on the European market from May 2021. However, device manufacturers were given until the 26th of May 2024 to recertify their products under the new legislation.

The MDR is an extended and improved version of the Medical Device Directive (MDD), and is designed to ensure consistent standards in the safety and quality of medical devices across 27 EU member states. At nearly 200 pages, the revised regulation is considerably longer and more comprehensive than its predecessor.

Demand for more clinical data to support claims, better control over the whole lifecycle and the parties involved in the manufacturing and distribution chain, alongside the need for more transparency, are key drivers in the change.

The new regulations set out new and revised responsibilities for the supervising agencies such as Notified Bodies, Competent Authorities, EU commission and even the European Medicines Agency (EMA) for drug products. These include:

• A detailed review of the provided clinical evidence by agency assigned external or internal clinical experts.
• Collaboration between agencies for combination products, such as medicines with a device and/or devices which contain an ancillary medicinal substance.
• A consultative role in case the notified body and manufacturer are not clear about qualification and/or risk classification of a product.
• Provision of regulatory guidance documents (MDCGs) via the coordination group, publication of common specifications, and guidance on borderline products which do not conform to a specific framework.

So what are some of the key changes, and how do they impact the manufacturing of medical devices for the European market?

Important Changes

The big news is that even existing medical devices, compliant under the previous regulations, will require re-certifying. At the same time, the number of agencies authorized to certify products has more than halved from 70 to less than 35 today. That means the competition for certification is fierce, forcing smaller and medium-sized medical device companies to join the back of the queue.

From sterilizers and syringes, to software and scanners – there are thousands of medical devices which need recertification before the deadline in 2024. Under the previous legislation, companies could – for class I devices – self-certify the safety and efficacy of their products. With MDR, several categories of devices have up classified, requiring approval of a notified body after which they will inform the relevant authorities.

Unsurprisingly, the approval process requires extensive and detailed documentation compiled in a dossier. Even previously approved devices will need their documentation and labelling revised in line with the new regulations. Furthermore, products which previously fell outside the remit of MDD, such as some cosmetic devices and devices without intended medical purpose, will now be subjected to the requirements of this new regulation for medical devices.

There’s also more stringent equivalence criteria when intending to re-use safety and performance data between seemingly similar devices, and for transparency there is the introduction of a unique device identifier (UDI) to track devices throughout the supply chain. That’s because the supply chain has risen to the forefront of the new rules. The MDR looks at every piece of the chain, including where components and raw materials are originally sourced.

Getting The Right Support

Whether you produce one medical device or hundreds, the clock is ticking to ensure your products are correctly certified for the EU market by 2024. Preparing the required technical dossier is an enormous task, and one that for some devices can even take up to 9 months or more.

However, help is at hand. Peercode both offers an end-to-end consultancy service and is able to produce medical device software. Peercode can be your advisor or even be the contracted medical device software manufacturer. What that means is that when it comes to complying with the latest regulations from the EU, or anywhere else for that matter, we offer a range of services to smooth the path to certification.

Interested to discover how Peercode can help ensure your medical device is compliant for the EU market? Take a look at our full range of services.

View our regulatory consultancy services.