Current trends, compliance pain points and regulatory updates discussed during MEDICA.
Obelis Group was present at MEDICA 2021, the largest medical trade fair in the world, for the 18th consecutive year. The event took place in Dusseldorf (Germany) between November 15 and 18.
MEDICA has been firmly established on our calendar all these years, and it was a bliss meeting people again at the live fair after such a long time. The Obelis team, comprised of Regulatory Consultants, they had the opportunity to meet with over 400 manufacturers from more than 50 countries in MEDICA’s halls and get important insights about the latest updates in healthcare.
Obelis introduced its UK and Swiss services, and we offered advice on the MDR and IVDR, whilst introducing the new regulations for Switzerland and UK. Obelis Group strives to support medical devices’ compliance and educate manufacturers on the DOs and DON’Ts when introducing medical equipment to Europe, the United Kingdom, and the Swiss markets.
Among the hot topics we discussed during the show was the MDR requirements for Europe, and the challenges that come with it.
Furthermore, we got many questions about the new requirements for Switzerland, as from May 2021, non-Swiss-based manufacturers must designate a Swiss-based Authorized Representative. We understand that complying with the latest Swiss requirements is a daunting task, so we made sure that we shared all the needed information on what EU/non-EU (non-Swiss based) companies need to do to enter the Swiss market with their medical devices.
IVDR was also in the spotlight, as many companies are preparing for the date of application in May 2022. We discussed the latest updates on IVDR, the extended transitional provision for some IVDs and the steps to comply by the 2022 deadline.
Manufacturers are anticipating the changes happening with the IVDR, the potential delays it might cause and the difficulty to appoint a Notified Body under IVDR.
“Most of the Notified Bodies are fully booked by now”, manufacturers mentioned.
The other concerns were Swiss and UK representations now that Brexit is official and Switzerland has new requirements. This experience manifested the need for a better understanding of the EAR under MDR requirements for non-EU manufacturers going through a notified body for their upper-class medical devices.
Once again, MEDICA turned out to be a great success for Obelis Group! To all the people we met: it was a pleasure to hear your thoughts on the medical landscape and, most importantly, to get your feedback on the daily regulatory challenges you are facing.
If you missed us at MEDICA 2021, do not worry: you can still schedule a call with our experts and learn more about the compliance for medical devices in the EU, Switzerland, and UK.