13 July 2018 - Authored by:
In this post of our “Getting ready for the EU MDR” series, we look at some key changes concerning Notified Bodies introduced by the Medical Devices Regulation (MDR), and how they may affect medical device manufacturers.
Some of these changes are already taking place and some will happen in the near future.
- Designation and monitoring of Notified Bodies
Among other things, the MDR aims to overcome the current divergence among different EU member states as regards the designation and monitoring of Notified Bodies by the national competent authorities.
First, Notified Bodies will be able to issue MDR CE-mark certificates only if they will be designated under the MDR rules. The MDR provides a new designation procedure which entrusts a greater role to the EU institutions in the examination of the application for designation. After submission of a designation application to the relevant member state, the European Commission, the new Medical Devices Coordination Group (MDCG) and joint assessment teams will participate to the assessment of the application. The ultimate decision on the designation of a Notified Body remains with the individual member state, but the MDR provides stricter and more detailed criteria that the member state must follow during the assessment procedure.
Notified Bodies have already started to apply for MDR designation since 25 November 2017, further to a Commission implementing regulation providing a list of codes for the designation of notified bodies under the MDR. Manufacturers are advised to contact their Notified Bodies and ask whether they have already applied and, if not, when they are planning to do so. According to NBOG’s Best Practice Guide, it is expected that the notified bodies that have applied first will obtain MDR designation in July 2019, less than a year before the application of the MDR. Team-NB, the European Association for Medical Devices of Notified Bodies, has published a list with its members’ intention to submit their application to be designated under the MDR.
At the moment, 59 Notified Bodies operate under the Medical Devices Directive (MDD) and 14 under the Active Implantable Medical Devices Directive (AIMDD) according to the Nando information system. New MDR criteria for designation may cause delays to some Notified Bodies to get their designation or, in the worst case scenario, lead them to withdraw from the market.
The MDR also strengthens the rules on the monitoring of Notified Bodies. Authorities responsible for Notified Bodies must reassess at least once a year their compliance with the MDR requirements. Additionally, authorities must proceed to a complete re-assessment three years after the first notification and then every fourth year.
- Unannounced audits
Under the current MDD/AIMDD system, Notified Bodies may pay unannounced visits to the manufacturer. However, they are not legally bound to perform these on-site controls. The MDR strengthens the position of Notified Bodies vis-à-vis manufacturers by introducing the duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance. In particular, the MDR provides that Notified Bodies must randomly perform unannounced audits on the site of the manufacturer and, where appropriate, of the manufacturers’ suppliers and/or subcontractors at least once every five years.
While in practice manufacturers are already subject to unannounced audits by their Notified Bodies, they should consider updating their operating system and procedures in order to be well prepared for the upcoming mandatory unannounced visits.
- Expert panels
The MDR introduces a new consultation procedure for certain class III and class IIb devices. Notified Bodies must, in addition to the applicable conformity assessment procedures, request from an expert panel to scrutinise their clinical evaluation assessment report. This request must be made through the European Commission. The aim of this new additional step is to harmonise evaluation of high-risk medical devices by sharing expertise on clinical aspects and developing Common Specifications on categories of devices that have undergone that consultation process. While Notified Bodies are obliged to request expert panels’ opinion, they are not obliged to follow the opinion indicated by the expert panel. However, Notified Bodies will have to justify their decision.
The European Commission will designate these expert panels by means of implementing acts on the basis of their up-to-date clinical, scientific or technical expertise. Manufactures must be informed on relevant delays for conformity assessments requiring consultation from an expert panel or additional fees.
As we approach the date of application of the MDR, it is important for manufacturers to understand the relevant consequences that changes related to Notified Bodies may have on their business and work closely with them while transitioning to the new regulatory framework.
This post was co-authored by Eftychia Sideri & Marco de Morpurgo.