Although COVID-19 continues to paralyze the global economy, there might be a few companies out there who are getting ‘lucky’ in the sense of a prolonged period to finish what has been looming over their industry for three years: the new Medical Device Regulation. What does postponing the MDR mean for manufacturers, Notified Bodies, patients, and the MD industry?
If we allow ourselves to look beyond the crisis for a moment it is apparent that not all Medical Device manufacturers are ready for this new regulation. And that being said, neither are the Notified Bodies.
European Commission spokesman Stefan De Keersmaecker last week on Wednesday on a a possible delay:
"We are working hard to submit this proposal early April and we call on Parliament and on Council to adopt it quickly as the deadline for entry into force is at the end of May. This will relieve pressure from national authorities and industry, and it will allow them to focus fully on urgent priorities related to the coronavirus crisis.”
What does postponing the MDR mean for manufacturers?
Speaking generally the MDR is primarily meant to enable safer Medical devices on the market with improved transparency regarding post-market surveillance. On the other side of the medallion, it was also expected to bring higher costs during development and more stringent regulations that severely delay the time to commercialization.
There are also some significant changes. For instance, Article 120 (3) of the MDR allows MDD Class I-devices that are classified 'up' from the MDD (mostly software), and, devices with a valid MDD CE-Certificate, to be placed on the market after the Date of Application (DoA) of the MDR. When a manufacturer processes a significant change after DoA , they need to comply to MDR. Definetly sometyhing to include in your MDR implementation plan.
That being said, Medical Device manufacturers throughout the EU were already facing plenty of challenges posed by the new MDR and many companies had already stated they are insufficiently prepared and feel the stringent timelines were unrealistic. In particular, the smaller companies could be forced out of a job because they are unable to comply with the MDR by the current date of application (26 May 2020), whether it is because of lacking resources or not being able to make the timelines.
Shortly, for manufacturers it would reduce the workload during the coronavirus crisis.
Tips for these companies? Re-assess and continue your MDR implementation plan and focus on the MDR focus areas:
More and more stringent requirements on clinical data
Periodic safety updates
Person responsible for regulatory compliance
Similar to but not the same as QP
Up-classification of medical devices
Inclusion of products with no medical benefit
And what about the Medical Device Industry?
It could be argued that the new MDR wasn’t exactly improving Europe’s position as an entry point into the global medical device market. This argument relates to costs of introduction mostly, which was significantly cheaper in de EU than the US under the previous Medical Device Directive.
What does postponing the MDR mean for patients?
The current demand for healthcare equipment (e.g. mouth guards, diagnostics, and breathing machines (and so on)) caused by the COVID-19 crisis is obliging Medical Device companies to work around the clock to supply their clients around the world. Keep in mind that this is on top their regular supply to patients and hospitals and that Medical Device manufacturers’ themselves are also affected by COVID-19, business-wise. Taking this into account, it shouldn’t come as a surprise that additional tasks to comply with the new Medical Device Regulation might lead to a lack of focus on making sure that patients have access to the devices they need to stay healthy.
Besides, many of the Medical Device companies have already had to make difficult strategic decisions to prioritize certain products (most likely products that generate the greatest sales to cover the costs of increased compliance requirements that are inherent to the new MDR). Needless to say, these products are usually chosen over other, less economically viable products that might very well be improving the quality of life for some patients, nonetheless. Perhaps the extra time will mean that companies have the extended possibility to get all of their products certified under the new MDR or perhaps new products will be developed to take their place. in any case, both scenarios would lead to a larger spectrum of Medical Devices that are available to patients.
What does postponing the MDR mean for Notified Bodies?
Because all notified bodies needed to be re-accredited, which means performing joint assessments for initial designation, extensions and scope-expansions, the entire process was estimated to be completed in approximately 18 months. Optimistically speaking, manufacturers would not have known until into 2019 if their current Notified Body would still be accountable for their companies’ products.
Needless to say, there were already doubts about the ‘readiness’ of European authorities that are supposed to be the framework behind the MDR but last January 2020, only twelve Notified Bodies had actually received their required accreditation. And as an interesting side-note it should be mentioned that out of the + - sixty Notified Bodies in Europe, not even half of them were pursuing re-accreditation. So, additionally, the total amount of notified bodies is suspected to be reduced in the future together with their respective scope on devices within the industry. Postponing would also mean additional time to define an approach for specific Drug-Device combinations that will require a 'Notified Body Opinion' after DoA of the MDR (Art. 117 MDR). Neither the EMA, nor the Notified Bodies are currently prepared for this.
Did you know? You look up Notified Bodies in the Nando (New Approach Notified and Designated Organisations) Information System.
What does postponing the MDR mean for the Medical Device job market?
It is no surprise that regulatory authorities, Medical Device manufacturers, and basically all other related parties are next to waging war for qualified staff to implement the new regulations.
Postponing the MDR could possibly mean extra time for professionals to be trained by institutions and in the field. In this year extra, the job market would be allowed to make a more natural switch from professionals that are focused on MDD to the MDR.
As stated before, the EC is hoping to submit their proposal early April and this will most likely lead to many more arguments and discussion to get a clear overview of the way forward. Right now, some questions postponing the MDR would leave us with are:
Does the Medical Device Directive/Active Implantable Medical Devices Directive stay valid automatically in the interim?
What will happen to MDD CE-Certificates that will perspire in the meantime?
Can we expect a similar solution regarding implementation of the In Vitro Diagnostic Regulation (IVDR)? Although IVDR's start date isn't until 2022, diagnostic makers' preparations that would have happened this year is being equally disrupted by coronavirus response.
Blog by Nick Veringmeier