The AEMPS has launched a new portal setting out all the implications of Brexit for businesses in the healthcare sector. Among these is an issue affecting companies wishing to operate in both markets: the adaptation of labelling and instructions for use for medical devices in the wake of Brexit.
Let’s bear in mind one date: 25 May 2021. This is the deadline set for bringing the labelling and instructions for use of medical devices into line with Brexit requirements, following the extension of the deadlines last May.
Before that day, all companies in the sector Medical Devices They must have submitted their Medical Device Marketing Notifications (CCPS) together with the up-to-date documentation.
Adapting the labelling and instructions for use of medical devices in light of Brexit – Every day we are getting closer to facing the consequences of Brexit and seeing how it will affect the markets and their products. A couple of weeks ago, the AEMPS launched a new website aimed at businesses and individuals, where we can find the official information on all the implications of Brexit for the healthcare sector. And eAmong these are those relating to medical devices.
In fact, almost a year ago, in May 2020, there was a major development in the sector. And that is The deadlines for bringing the labelling and instructions for use of medical devices into line with the new requirements have been extended who are affected by Brexit. And unless a further extension of the deadlines for this transition is agreed – which is rather unlikely – this news has clear implications for manufacturers of medical devices: all lCompanies have until 25 May 2021 to update their marketing notifications for their medical devices with the CCPS.
What new features does the AEMPS’s new Brexit portal offer?
It is true that this new portal, as regards medical devices, does not provide much new information on the original press release published by the AEMPS itself in May 2020, which was already quite comprehensive. In short, this first press release extended the deadlines for companies to make the necessary changes to labelling and instructions for use.
Even so, the website is useful for professionals, in that we can find all AEMPS press releases relating to Brexit, information on the European Commission Working Groups y links to other important official publications, such as those in the Moncloa, those of the European Commission and the European Medicines Agency (EMA).
Furthermore, the AEMPS, through the publication of the new Brexit information portal, serves a dual purpose:
- We would like to remind you once again that the deadlines (which have already been extended) for companies in the sector to bring their labelling and instructions for use into line with the new regulations are due to expire shortly.
- We would like to remind UK companies wishing to comply with the regulations on labelling and instructions for use that they must make the necessary changes by 25 May 2021
The COVID-19 pandemic and the recent publication of the new Medical Devices Regulation 2017/745 make it difficult to bring labelling and instructions for use into line with the requirements: the European Parliament extends the deadlines
It is important to understand what led to the extension of the deadlines to enable the European authorities to adapt to Brexit. At the time of the AEMPS’s initial publication, the health situation across the EU, the pandemic was having an impact at many levels COVID-19.
It is clear that, throughout the State of Emergency and the subsequent clockdown, many companies in the healthcare products sector have had additional challenges / unforeseen consequences -whatever you choose to call them- relating to the pandemic (including, of course, the necessary adaptation of their internal routines to working from home).
Having assessed the health situation as it stood in mid-2020, and on the advice of a wide range of stakeholders – industry, professional associations, etc. – the European Parliament finally decided to give businesses a little more leeway to adapt to the new regulations and to extend the suitability of labelling and instructions for use.
Little by little, the deadline set following the extension is drawing nearer. And unless there are exceptional circumstances that would justify a further delay, we should have submitted the Marketing Communications for Medical Devices for each of the products we have on the market.
Do you need to update your marketing communications for medical devices before 25 May 2021? Are you unsure whether your business is affected by Brexit? Would you like to know what steps to take to adapt to Brexit and remain safely in the EU market? Consult an expert!
At Gabinete Técnico Farmacéutico M. Camps, we can update the information relating to your marketing communications in CCPS. We have a a wealth of experience in rregulatory affairs Medical Devices. And we are ready to provide technical solutions for your business.
Don’t let Brexit become an obstacle to your project – turn it into a new business opportunity. Get in touch!
Important note: To update the marketing communications for medical devices in CCPS, simply send us an email requesting this update and authorising us to carry it out on your behalf using your login details. Please email us at gtf@mcamps.com and we’ll help you with any queries you may have about medical devices in the wake of Brexit
Once the communications at CCPS, these may remain in a “Draft recovered” to be completed and submitted to the AEMPS, provided their content remains up to date. This means they can be submitted gradually, as and when they need to be updated.
We would like to remind you of the obligation to keep all contact details up to date and to notify us of any cancellation due to the cessation of trading.
Notifications that are to be withdrawn must also be retrieved – even if the documentation is not updated – and sent to the AEMPS via CCPS, from where the company can then withdraw them in order to ensure that the traceability of the notifications is properly maintained.