The Clock is Ticking …
Everyone should know by now that the MedTech Sector is in a transition period to achieve compliance with the new EU Medical Device and IVD regulations. Full enforcement of the EU Medical Devices Regulation is effective as from 27 May 2020 and for the EU IVD Regulation, it is 27 May 2022.
It’s now a year until the first deadline so how are things going?
These are decreasing in number. A few years ago, there were 83 EU Notified Bodies, this has now reduced to 55. Out of that 55, only approximately 30 Notified Bodies have applied to be re-accredited under the new EU Regulations. Out of these, the number of Notified Bodies who are willing to support Class III Medical Devices (i.e. the most high-risk devices), has also significantly reduced. This means that there is an ever-decreasing pool of Notified Bodies to choose from and even less if you have a high-risk device.
So out of those who have applied to be accredited under the new EU Regulations, how many have been successful? So far … one! This is the BSI in the UK which, when you consider Brexit, is not good news. As soon as the UK leaves Europe, BSI’s accreditation will be of no value whatsoever. Fortunately, they have set up in Amsterdam so that they still have a presence in Europe and I understand that they are busy transferring certificates to their new Dutch entity.
So as to buy more time, many manufacturers are recertifying their existing devices under the ‘old’ Medical Device Directive. Potentially, these certificates will remain valid until 27 May 2024. Of course, this has a ‘knock-on’ effect in that Notified Bodies, who are already under pressure because of the new requirements, are being approached by more manufacturers for re-certification. There is a distinct lack of resource and time to cope with this additional workload.
Very recently a statement has been issued that the Competent Authorities of the Member States are going to ‘step in’ and provide the necessary support so that medical devices can remain on the EU market thereby ensuring patient treatments and safety. A small piece of positive news!
Very little in the way of guidance is available on how to interpret these new regulations. The first guidance was published by the European Medicines Agency (EMA) on 28th February 2019, nearly two years after the new regulations were published! There’s a lot more guidance on its way but … when?
Yes, this will bring another layer of complexity to the whole process but … if manufacturers approach this scenario in a logical manner and plan for a no-deal Brexit (i.e. worst-case scenario) then they will be well prepared for when it does happen. To be absolutely transparent, Brexit warrants a completely separate article to address every aspect of its potential implication so, we’ll leave that for another day!
Knowledge of the industry
Amazingly, there are still some Class I medical device manufacturers who state that they’ve not even heard of these new EU regulations! Even worse, some of them didn’t even know that they were registered on their Competent Authority’s website!
What can be done?
- If this is the first time you’ve read about these new EU regulations then you need to learn and fast! A good first step will be to engage a regulatory consultant to help you through the process.
- Keep an eye out for any new guidance and as soon as it is made available, familiarise yourself with this information, assess and implement as necessary. Med-Di-Dia can help by monitoring and interpreting this guidance for you which will save you stress, time and money.
- Get in touch with your Notified Body. Engage with them early and often. They are there to support you and it’s critical to co-operate and communicate with each other. It can be beneficial to have a regulatory consultant liaising on your behalf with your Notified Body after all they will have your best interests at heart but also understand the language and expectations of the regulators!
- Assess your current portfolio against the new requirements, identify the gaps in compliance, understand (and document) what you need to do in order to achieve compliance and compile a strategy on how to implement your findings. It’s usually best to get an objective viewpoint so to appoint someone outside your company to conduct these assessments etc, is usually of the greatest value and in the end, will save you time and money.
In this article, I’ve provided you with an overview and some key aspects which you, as a medical technology company, should be addressing.
I can’t emphasise this enough: there is a need to act and to act now.
If you choose ‘no action’, you run the very real risk of being left behind and with products you cannot legally sell within Europe.
Med-Di-Dia can help. Please don’t hesitate to contact us for a no-obligation, free-of-charge chat - Tel: + 353 (0)91-704804 or email: MDD@mddltd.com.