My Feedback - 7th Annual EU Device and Diagnostic Regulation Conference

Q1 Productions is one of a handful of medtech event organisers known for conferences at European level. Their 7th Annual EU Device and Diagnostic Regulation Conference took place the 25th and 26th September at the Park Inn by Radisson, Brussels. 

Below you will find a summary of the two days, some key quotes, pictures, and my thoughts on the overall quality of the conference.

The event was smaller than other EU medtech conferences, which is something I really liked. The focus was on the audience and the program content. Alexia Lynch, has been organising this event for a number of years. Her experience and knowledge of the key issues affecting the Medical Device Regulatory scene was impressive, and reflected in the way the event was organised. The discussion topics were relevant, her network of speakers were interesting and this led to a highly engaged audience.

Content

All presentation materials were available before the event via a shared dropbox. Having been to events with no copy of the presentation and no print outs on the day, I have to say, Q1 productions scored very highly for organisation.

The conference was split over 2 days, with day 1 addressing the more general MDR/IVDR topics, such as: what are companies doing to prepare, timelines, large VS small company impact and more. Day 2 was much more specific with an individual IVDR and MDR track that delegates could follow. 

IVDR Track Team

The calibre of speakers was high. I liked that we had a good spread of medtech’s heavyweights and smaller companies sharing their experience and perspective. 

We had the chance to listen to a fireside chat led by Philippe Auclair and representatives from the Cypriot and Belgian competent authorities. Cool, calm and confident, they reassured us that they are prepared and ready to deal with the demand the MDR would bring (!). It would have been interesting to compare their "readiness" with a representative from some of the larger competent authorities like MHRA or BFARM - (suggestion for next year?!).

Competent authority fireside chat

Workshops - This conference was a lot less about sitting and listening and a lot more about doing. We were split into small groups, given a case study and asked to figure out the solution. I really believe in active engagement, learning by doing. This was a great way to see how other people would tackle the same problem, learn from each other and then feed back each team’s solution with the room, encouraging group wide discussion.

Our PMS workshop team

Panel Discussions - As you may know, I had the opportunity to be a panelist for the discussion on resources. The focus was all on the audience - people were given the opportunity to ask their questions to us and share their views. I can definitely tell you this was unscripted, and I hope those of you who were there found this refreshing!

I was surprised to see that almost all of the bigger medical device companies had already put together their resource plan, and even more surprised that the vast majority of SMEs were still at the early stages of determining what they needed to do! There is no magic formula to determine how many resources you need, this is something that each company needs to look at case by case. We also discussed Article 15 - the role of a "person responsible for regulatory compliance", and possible solutions on how to organise the team so that recruiting a new headcount for this role would not be necessary.

Networking

On day 1 we had an interactive ice breaker activity; to go around and introduce yourself to people in the room with a fun fact. This really set the tone for the rest of the conference - with introductions out of the way the atmosphere was relaxed. People were shouting out questions, debating with the speakers and sharing their experiences, which led to a highly engaging day.

Ice Breaker Activity!

The audience was truly international, coming from Switzerland, Austria, Netherlands, France, Germany, Finland, Denmark, and even Australia (to name just a few!)

We had frequent coffee breaks, networking opportunities and delicious lunches over the course of the two days.

Q1 also organised facilitated group dinners at 2 different restaurants. This was so popular that one of the restaurants was oversubscribed! As a solo attendee - dinner alone is not always a fun prospect. It was really nice to meet new people, and discuss the day’s topics over a glass of wine.

Favourite quotes

MDR is a business project, not just a regulatory project - Matthias Buerger

To understand MDR, you have to READ the MDR. Be sure to have a glass of Whisky, you will need it - Bassil Akra

There are known knowns, there are known unknowns, and there are unknown unknowns. Beware of the unknown unknows - Philippe Auclair & Sue Spencer

"NO GRANDFATHERING" - Sue Spencer

Conclusion

If you are considering attending an EU based medtech event focussed on regulatory matters, I highly recommend Q1 productions. This conference is more than just sitting and passively listening. The combination of workshops and discussions give practical solutions to what can sometimes be a complicated and daunting task. I look forward to seeing you all there next year!