If you’re considering selling your medical device in Europe, you will need a Notified Body, and you’ll need to understand what role they play in making sure your device is compliant to the EU regulations. A Notified Body is an accredited organization by the EU and their major role is to conduct conformity assessments under the EU Directives, which involves auditing the quality system and reviewing technical documentation to support the safety and effectiveness of the device. If the device firm conforms to the regulations, the notified body will issue a CE certificate, which is required in order to market your device in the EU. A CE mark on a device is the claim that the device meets all the requirements of the regulations and can be sold anywhere in the European Economic Area.1 The process and intensity of the process will vary with the risk classification of the device, so it is essential that you allow a Notified Body to help you through the process.
Currently, in the EU there are over 50 Notified Bodies, so which one should you choose?2 Much like consultants or contractors, you want to make sure you select your Notified Body based on thorough research. Some selection criteria to guide your research:
- Is the Notified Body accredited to certify all classes of medical devices or just a select few? Even if you currently only manufacture one type of medical device, what if you eventually develop another device in a different classification? The Notified Bodies experience with different device classifications can also be beneficial from a training or best-practices approach.
- You’ll want to consider the size and staffing of the Notified Body. Larger bodies can typically offer a broader range of accreditation and experience with various types of devices, but smaller bodies may be able to offer more focused customer service and individualized consultation.
- A major thing to consider is how much work transferring from one Notified Body to another entails. Ideally, you should stay with whatever body you choose for many years; however, with so many options to choose, you may find one that better fits your needs as your company develops. Transferring from one body to another involves re-assessing CE certificates, revising documents/labeling, and potentially additional audits. It is important to select a Notified Body that you can see having a business relationship with even through many company changes and phases.
Notified Bodies are intended to help navigate medical device companies through the path to selling their device on the EU market but choosing the right body and understanding what they can do for you can be a confusing maze itself. Especially with the impending EU MDR, medical device companies can expect even more changes. If you need help with EU regulations, notified bodies, or CE marking, contact EMMA International at 248-987-4497 or info@emmainternational.com to see how we can help!
1BSI (n.d.) BSI Guide to Notified Bodies retrieved on 10/15/19 from: https://www.bsigroup.com/en-US/medical-devices/Our-services/What-is-the-role-of-the-Notified-Body/
2European Commission (n.d.) Medical Devices retrieved on 10/15/2019 from: https://ec.europa.eu/growth/sectors/medical-devices_en
