Medical device and diagnostics manufacturers are likely to face huge challenges to implement the new requirements imposed by the new European Medical Device Regulation. This does not so much refer to global players (or multinational corporations) and/or those with more than 250 employees. These companies will not be impacted as dramatically as they typically have the financial and human resources to cope with the upcoming changes in the certification process. Small and medium-sized companies will, however, find it harder to implement the new requirements.
Compared to the MDD, MDR 2017/745 introduces a life-cycle approach to ongoing CE Marking compliance. Risk Management is applied as a general concept not only for products but also for processes. Conformity assessment procedures are more complex, and equivalence will be more stringently interpreted.
Clinical data and Clinical Evaluation Report (CER) will face heavy scrutiny and require recurring updates. Manufacturers must also fulfill increased post-market surveillance requirements, perform more Post-Market Clinical Follow-up (PMCF) studies, and deliver Period Safety Update Reports (Class IIa devices and above).
Transitioning to the MDR might seem overwhelming and many companies don’t know where to start. Please find below a number of topics that need attention from SME manufacturers.
What is your compliance situation?
The first step is to assess your current level of compliance. A thorough gap analysis will generate a task list for updating your procedures and documentation.
Are you confident that your marketing claims are covered by clinical data?
A smart next step is to examine the marketing claims of your devices versus your current clinical data and to determine if this is documented sufficiently in the Clinical Evaluation Report to make sure you comply with MEDDEV 2.7/1 rev 4. There are several requirements in the MDR that go beyond what is required by MEDDEV 2.7/1 rev 4, e.g. PMCF report, PSUR/PMS reports, CEP/Clinical Development Plan and the Summary Safety & Clinical Performance amongst others. No formal templates are provided at this stage, but working with an experienced team will provide you access to best practice in this field. In the interim, compliance to rev 4 is a solid basis to finally meet also these MDR requirements. Notified Bodies are already requiring a higher level of overall quality for clinical evidence and complying with clinical data requirements will be a major hurdle for many companies.
Will you invest in all your devices?
In a next step, a portfolio assessment should be carried out to determine, for which products investments in MDR compliance are justified. This is especially critical for smaller enterprises with limited financial resources. It is helpful to have for each device a plan for remediation, retire, and/or transition.
How do you know your Notified Body is ready?
Another critical factor for manufacturers is the ability of their Notified Body to become designated in time for the full applicable scope of devices, relevant for the manufacturer.
There have been cases from notified bodies dropping a specific code or companies having been orphaned and not being able to be recertified by a new Notified Body in time, which turned out disastrous for the company involved. As a small manufacturer one might not get the same level of attention from the Notified Body as a huge multinational organization.
To avoid these situations, it is critical for any manufacturer to stay in close touch with their Notified Body to learn early about these risks and being able to react on time.
are already facing significant capacity issues with numbers dwindling in Europe, and the more stringent requirements set out by the MDR are very likely to escalate this existing issue. NBs
are in a particularly difficult position as there has already been a significant decrease in their numbers, but an increased demand on
their services is to be expected as the MDR rolls into force.
Do you know if the Classification of your devices will change?
Other areas to watch out for manufacturers are changing MDR Classification rules in Annex VIII. Manufacturers need to determine whether new conformity assessment routes are now applicable to their product portfolio. If so, they need to get in touch with their NB to take steps to make sure that all requirements are met in
the specific time frame. Especially critical are up classifications for class
I products, as in these cases there is a hard stop on 26 May 2020 if no CE certificate is available under MDR.
Do you have full technical documentation for all devices you market?
The MDR is going to be far more prescriptive about the required content of technical documentation, particularly as there are more detailed requirements for quality management systems. Manufacturers will have to ensure that they not only have full access and control of the technical documentation for all devices they market under their name but also keep an eye out for the publication on the new common specifications.
Under the new regulation, medical device manufacturers will be required to collect post-market clinical data as part of their on-going assessment of looming safety risks. Therefore, it is important that they review their procedures for PMS and ensure that the responsibility for the provision of this additional data and associated support is established clearly.
Are your IT processes ready?
Related to the upcoming UDI requirements manufacturers need to keep close
watch on the European Data Bank on Medical Devices (EUDAMED). Even though the database might not be fully implemented by May 2020, manufacturers need to be ready to notify all required data elements for all of their products once it has been implemented.
In terms of implementing the UDI requirement is not so much about the actual labeling of barcodes on the products, but about setting up the systems and processes to gather and maintain all the data required to be uploaded to the EUDAMED database.
With the new MDR touching on so many critical processes, it is imperative that manufacturers, but especially small manufacturers should be proactive. Implement a pragmatic strategy to ensure compliance before the deadline. Targeting the new changes in an isolated and siloed manner will not work; rather, manufacturers should look to appoint team members from various functions of the business to take responsibility for specific processes and adaptions. Small manufacturers might want to look for external partners that will support them in these efforts.
The changes implied by the MDR might also be an opportunity to upgrade tools and systems. It and might bring unexpected benefits as it is a good opportunity for manufacturers to audit their product portfolio and reap the benefits of enhanced core product focus.