EU MDR & IVDR Booklet for the Finnish Health Tech Industry
Business Finland has been seeking ways to make the transition into the new EU Medical Device Regulations MDR & IVDR smoother for the Finnish health tech sector, and especially for the small and medium size enterprises. We now announce our plan to publish a 101 guidance booklet with focus on the MDR & IVDR in December 2020. The work will be carried out by Lean Entries together with Tom Ståhlberg, who's narrative in the original booklet published by Tekes regarding the current EU Medical Device Directives has been widely appreciated by the Finnish health tech industry. The new booklet will be published in English and it highlights efficient regulatory compliance not only as a business mandatory, but as a business advantage, guiding innovators to systematically develop safe and effective solutions.
Webinar: Thursday 17 December 2020 at 13:00-16:00
Following the publication of the booklet, Business Finland with Lean Entries and Tom Ståhlberg will hold a three hour online event on Thursday 17 December 2020 to help readers reap the benefits of the booklet and bring to surface the most important topics towards the May 2021 and 2022 transitions into the MDR and the IVDR respectively. The event will be opened by Kari Klossner from Business Finland followed by three one-hour sections with breaks. The first two follow the booklet narrative and the third will focus on questions, answers and discussion on the effects of the MDR and the IVDR for the industry today and as far into the future as the eye can see.
Program of the day:
13:00 - 13:10
Opening Words from Business Finland - Kari Klossner
13:10 - 13:20
Quick introductions by Authors & Polling to Attendees to Know Who's Online
13:20 - 13:35
An Overlook on the Book: European Medical Device Regulations MDR & IVDR - A Guide to Market - Heikki Pitkänen
13:35 - 14:20
Chapters 1-4: From EU Legislation to the Regulatory Path to CE marking - Tom Ståhlberg & authors
14:25 - 15:10
Chapters 5-8: From the Intended Purpose to Compliance throughout the Device Life Cycle - Heikki Pitkänen & authors
15:15 - 16:00
Panel Discussion, Questions & Answers on the MDR & IVDR - Heikki Pitkänen, Leena Raunio, Ilona Santavaara, Tom Ståhlberg
Please note that the event will be organised in Finnish. Read more on Finnish pages.