Medical device regulation: What’s the impact on Notified Bodies?
The medical device sector is in a state of significant uncertainty at the moment as it prepares for the introduction of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) due to be fully applied in 2020 and 2022 respectively.
Paul Brooks, executive director at the Regulatory Affairs Professional Society (RAPS) discusses how Notified Bodies are preparing as they transition to the new regulations and the wider impact that this has on the medical device sector.
Regulatory outlook
The new MDR (2017/745) and IVDR (2017/746) will replace the EU’s current Medical Device Directive (MDD) (93/42/EEC) and In Vitro Diagnostics Directive (IVDD) (98/79/EC) to ensure greater confidence in the effective protection of public health and patient safety.
The new regulations were officially published in May 2017 and entered into force later that month. They include important improvements to modernise the current system, such as stricter pre-market requirements for higher risk devices, much more prescriptive and demanding criteria for designation and processes for oversight of Notified Bodies. They also refer to the inclusion of certain aesthetic devices, improved transparency, reinforcement of rules on clinical evidence and strengthening of post-market surveillance as well as improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.[i]
Preparation is key
Under the new regulations, stricter requirements will be imposed on Notified Bodies and all existing Notified Bodies will have to apply for and achieve new designations. Consequently, it is essential that they are already preparing themselves to demonstrate compliance with the new requirements and are correctly anticipating the expectations of the European Competent Authorities and European Commission (EC) Medical Device Coordination Group (MDCG). Equally, it is most important that Notified Bodies have thoroughly reviewed the newly proposed product codes and have considered how to demonstrate competence across the codes when submitting applications for Notified Body designation. From the perspective of EU member states and manufacturers, it is important that a selection of Notified Bodies are able to achieve designation for each and every code (otherwise it will not be possible to get CE marking/market clearance for devices related to those codes).
Early designation under the new regulations is also important as it is predicted that during the transition time manufacturers will need to work with the Notified Bodies to calibrate and clarify the interpretation of the expectations. It is in the interest of all stakeholders to ensure the consistent application of the new requirements early on. This will enable a smoother and more efficient transition into regulatory compliance with the new regulations, ensuring minimal disruption to the market access of all legacy and new devices.
Increased pressures
Notified Bodies are required to now demonstrate increased, more granular technical expertise in their scope of designation, as well as improved quality management systems. They will be initially audited jointly by the local Competent Authority, another member state Competent Authority, and EC representatives. Also, re-audits will occur more frequently and more consistently across all Notified Bodies than currently. All this has put Notified Bodies under additional and appropriate significant pressure and is demonstrative in the decline in the number of active Notified Bodies. Before the publication of the regulations, there were over 83 Notified Bodies under the current MDD, yet as of October 2017 there are already significantly fewer (<52)[ii] and further reduction in Notified Bodies is expected as the designation process under the MDR proceeds. As of the end of October 2017, there are 23 members of The European Association Medical Notified Bodies (TEAM NB) who have announced their intentions and timelines for applying for Notified Body designation under the new MDR and/or IVDR[iii].
As with all transitions between regulatory updates, there is an element of ambiguity with certain ‘grey areas’ which will require individual interpretation and more guidance before acceptance by all stakeholders is achieved.
All these additional requirements in turn lead to a significant investment of resources not only in the improved quality processes but also in increased employee training in order to meet these more prescriptive and demanding regulations. While it is clear that larger Notified Bodies can support this investment, it’s unclear whether smaller ones will be able to meet all the demands of the MDR and IVDR.
Attracting talent
With the combination of increasing pressures, it is perhaps becoming much less attractive to enter into the Notified Body business. It has been reported that in an attempt to find new expert staff, some Notified Bodies are competing to attract auditors and product experts from each other or from industry. Industry is also looking for replacements for lost knowledgeable staff members and is attracting personnel from Notified Bodies. Competent Authorities and the EC are also looking for more expert staff members. This has the potential to impact the capacity of Notified Body services especially as Notified Bodies now need to hire, train and ramp-up auditors and staff with higher competence and expertise to ensure they comply with the new MDR and IVDR.[iv] This in turn makes it a very competitive landscape where Notified Bodies will need to do much more to retain their talent.
Challenges for Notified Bodies
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has estimated that there may be more than half a million different devices currently CE marked under the directives that must transition to fully comply with the new regulations. This clearly has an impact on not only the workload of Notified Bodies, but also their capacity to complete all the necessary conformity assessments now required for compliance with the MDR. Under the MDR, there is much greater emphasis on a higher number and more thorough reviews by Notified Bodies to confirm manufacturers are fully compliant and devices are fully supported by adequate data and technical documentation. Under the IVDR the workload compared to the IVDD increases many fold hence the longer transition period.
There is the potential for significant backlogs toward the end of the transition period so waiting too long could be a particularly risky strategy for a manufacturer.
As already discussed, re-designation is an important part of the new regulations for Notified Bodies to continue to operate. However, many currently designated under the MDD may not achieve designation under the MDR, or may decide not to apply for the designation which again has many repercussions for the future of the medical devices sectors. Even if a Notified Body decides it is ready to apply for designation under the new regulations in applications, it is estimated that no designations will be confirmed for a further six to nine months, pushing Notified Body MDR designations well into 2018 and further reducing the transition period available before May 2020.
It’s also important to note that the uncertainty and unknown future following the outcome of the EU referendum in the UK has added to the stresses of UK Notified Bodies. This is encouraging them to consider contingency plans so that they are able to continue to work in the event that the current UK negotiations with the EU fail to reach agreements. The British Standards Institution (BSI), for example, has already established a Dutch Notified Body unit in the Netherlands just in case it is unable to continue to operate fully from within the current UK HQ.
Final thought
Advanced preparation and early action will be key to ensuring a smooth transition to the new requirements. It’s evident that there is a much greater level of communication taking place in the industry between the relevant Authorities and all stakeholders, with industry training sessions taking place throughout the EU as well as workshops that aim to educate the industry and allow for a much clearer adoption of the new regulations.
[i] http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en
[ii] http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=na.main
[iii] http://www.team-nb.org/wp-content/uploads/2017/10/Team-NB-MDR-IVDR-Application-20171030.pdf