insights
Part 3 in our 7-part series on meeting the new requirements under the EU MDR
If you are new to obtaining marketing approval in the European Union, the concept of Notified Bodies is one of the most significant differences from the US FDA system or regulatory oversight.
A Notified Body is an independent certification organization that is “notified” by an EU member state’s Competent Authority, usually the ministry of health, to certify that a product meets the applicable requirements for CE marking.
The Notified Body’s primary task is to provide conformity assessment services according to the relevant regulatory standards. Under the current MDD regulations, there are 83 medical device Notified Bodies throughout the EU, which need to re-certify under more stringent requirements for Notified Bodies under the MDR.
New or more stringent NB requirements
According to Med Device Online, Notified Bodies face a number of new requirements under MDR. NBs are now required to:
- Demonstrate increased technical expertise in their scope of designation
- Show improved quality management systems
- Undergo triple audits – initially NBs will be audited jointly by the local Competent Authority, another member state Competent Authority, and Commission representatives
- Perform unannounced and a more frequent schedule of audits of manufacturers and authorized representatives
- Schedules of audits need to be provided to the national authorities ahead of time
- Consult with the European Commission regarding adequacy of NB’s clinical evaluations and post-market clinical follow-up for NBs granting certificates for Class III implantable and IIb devices intended to administer or remove medicines
- Show surveillance assessments that include a test of the approved parts and/or materials essential for the integrity of the device, including a check that the quantity of purchased parts corresponds with the quantity of finished devices
- Witness tests and reconciliation activities that will take place during on-site audits to ensure that the quality management system (QMS) is working properly.
As a consequence, many smaller NBs may be unable to re-certify or will qualify for re-certification for a narrower scope of products. On the positive side, it is predicted that most of the larger NBs will apply for recertification under MDR and/or IVDR and are likely to expand the scope of their auditing capabilities.
In addition, due to the need for increased technical expertise, MedTech Innovation News reports there is increased competition to hire a limited number of subject-area experts. Not only are NBs competing with each other, they are also competing with Competent Authorities and the Commission itself who are all looking to add expertise.
Given the challenges facing Notified Bodies, Q1 Productions, a management and market research firm, predicts a certain kind of bottleneck is being created for medical device makers trying to simultaneously maintain CE Marking under MDD through the transition period, and preparing for submissions under MDR.
What can device makers do?
If you have existing NB relationships, keep in close contact with them. If possible, obtain audit dates earlier than you might otherwise do. Build more time into your schedule for technical file reviews. If you are subject to QMS implementation, get started as soon as possible. If you are a startup, establish a relationship with an NB immediately, regardless of your time frame to market. If you find you need to switch NBs, start early and be persistent.
If you are looking for help with MDR, Kapstone Medical has the experience and expertise medical device manufacturer requirements from submissions to compliance. Contact us for more information.
Sources: Med Device Online: 8 Key Changes To Understand In The New European MDR And IVDR; MedTech Innovation News: Medical device regulation: What’s the impact on Notified Bodies?; Q1 Productions: Impact of EU MDR on Notified Bodies; Oriel A Matrix: Number of Notified Bodies Pursuing MDR and IVDR Certification Continues to Dwindle
