One of the key challenges for medical device companies operating within the EU market is that there are not enough notified bodies to meet the demand for (re)certification. Secondly, incomplete documentation, which omits required information, is causing lengthy delays within the application and review process. Is there a faster way to get certified?

In The Waiting Line

Right now, even joining the queue to ensure your medical device will be reviewed for certification in time is an issue. Demand for certification far outstrips existing capacity within existing notified bodies. In fact, some industry experts claim that just to process all recertifications, based on current available resources, it could take notified bodies until 2050 – 25 years later than the current deadline. What needs to change?

To a certain extent, notified bodies have their hands tied. There are only so many accredited auditors to complete the work necessary to review the manufacturer's in-house quality management system (QMS) procedures and their technical documentation. New auditors, when they can be found, need to be trained at the notified bodies, and it takes time to become fully qualified.

At the current time, notified bodies just lack the necessary resources to increase the volumes of applications processed, whilst ensuring government imposed quality standards. Suitably qualified auditors are being pushed and pulled in separate directions. On the one hand, they’re needed at the notified bodies. On the other hand, medical device companies need their services as well to get their QMS and dossiers MDR compliant.

Ticking The Right Boxes

It may sound obvious, but having a complete checklist of the required documentation and standards is one way to speed up the certification of medical devices.

With a robust and ready-to-go dossier, it’s much easier for the notified bodies to process applications – they have everything they need on one plate.

This means companies should provide all the relevant evidence, and quality check the technical documentation within dossiers, including:

• Defining the various requirements
• Documenting specific methods
• Using state-of-the-art standards
• Evidencing the requirements’ verification testing
• Validation of end product.

By doing and recording this, companies can be helped to accelerate the certification process.

The Right Clinical Evidence

The kind of evidence required depends on the type of device being submitted for certification. So when companies haven’t read or followed the right or specific guidance, they end up producing evidence that’s not needed or doesn’t meet the relevant requirements.

Manufacturers not only need to get up to speed on what the MDR means for their products, but they also need to be aware that there is guidance out there to help them achieve a compliant file for certification. They have access to the same guidance as notified bodies, which can help them ensure they meet the right criteria.

Producing a complete and correct dossier, makes the job of the notified bodies much easier. It also mitigates time-consuming back and forth with manufacturers as errors and omitted information is identified and corrected. Getting it right the first time is what every manufacturer should be striving for. The deeper their insight into the requirements, the quicker and easier their dossier can be processed by a notified body.

Know Your Product

A clear and well-written dossier leaves notified bodies in no doubt as to what your medical product does and how it conforms to the MDR. This clarity is crucial. After all, they’re the gatekeepers for getting your product to market.

By giving our customers clear oversight of the procedures and checklists followed by notified bodies, we help to ensure that every aspect of their dossier meets the required standards for the relevant fields, and expedites its progress through the certification process.

Find out how Peercode Regulatory can help bring your medical device to market faster. Explore our services.