Last week Paola Sangiovanni and Flavio Monfrini participated, as speakers, to a webinar on the implementation of the MDR and IVDR.
The webinar was hosted by the firm Axon Lawyers based in Amsterdam and was especially interesting as members of the Alliance of European Life Sciences Law Firms in France, UK, Germany, Belgium, Greece, Spain, Belgium and The Netherlands contributed their expertise.
If you have missed it, worry not: you can find its registration here .
Save the date for Friday 18 November from 15:30 to 17:00 CET for a unique webinar about implementation of the EU MDR and IVDR in various European member states and recognition of CE marked devices on the UK market, hosted by the Alliance of European Law Firms in which medical devices legal specialists from Spain, Italy, the UK, Germany, Greece, Belgium and the Netherlands will address:
- A compare and contrast of how competent authorities in the respective countries deal with the concepts of placing on the market and making available under the MDR and IVDR, both crucial concepts for upcoming regulatory deadlines (and maybe some news on where we expect things to go with the MDR and IVDR);
- A compare and contrast of national implementing measures for the MDR and IVDR, such as regarding sanctions for non-compliance, enforcement policy and specific subjects where the MDR and IVDR allow significant local discretion (e.g. reprocessing of single use devices and as regards in-house produced devices);
- A compare and contrast of national exemption possibilities under articles 59 and 97 in view of expiring MDD/AIMDD/IVDD certificates and not timely obtain an MDR / IVDR certificate.
Do not miss out on this unique opportunity to have all your questions about medical devices and IVD regulation implementation in the UK and important EU member states addressed by our expert panel:
- Francisco Aranega from AMyS Law (Barcelona, Spain)
- Laure le Calve from LCH Avocats (Paris, France)
- An Vijverman from Dewallens & Partners (Leuven/Brussels, Belgium)
- Ioanna Michalopoulou from Michalopoulou & Associates (Athens, Greece)
- Mathias Klümper and Claudia Lützeler from Lützeler Klümper (Hamburg/Düsseldorf, Germany)
- Paola Sangiovanni and Flavio Monfrini from Gitti and Partners (Milan, Italy)
- Alex Denoon and Xisca Borras from Bristows (London, UK)
- Erik Vollebregt from Axon Lawyers (Amsterdam, The Netherlands)
If you would like to attend, please send us an email to email@example.com and we will provide you with a link and technical information on joining the seminar well in advance.
Please feel free to share this save the date with colleagues or other people that may find the seminar interesting. If they send us an email, we can send them their own link and information for joining the webinar.
Still confused about the regulatory changes affecting medical devices and in vitro devices? The EU Commission has published a useful factsheet, which you can find here.
Through the factsheet, the Commission warns health institutions and healthcare professionals that the upcoming changes may have consequences on the availability of medical devices because manufacturers may decide to stop their production or because products may not get their certificates on time.
Some notified bodies have also decided to drop off and only two notified bodies have been MDR designated so far, so this will create additional bottlenecks. A short grace period until 2025 is granted, but it does not apply to class I devices.
The path to an enhanced regulatory framework will be complicated and manufacturers, healthcare institutions and healthcare professionals need to know what to expect.