19 Feb 2020

Are you ready for Medical Device Regulations?

General info

Allanta

Allanta members participate in € 250.00 per person. From the second participant only € 200.00 per person.

Non-members: € 400.00 per person. From the second participant € 300.00 /per person.

Novotel Leuven Centrum
Vuurkruisenlaan 4
3000 Leuven
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Parking Vaartkom
Engelsplein 32
3000 Leuven
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This is the key question for which we are looking to find answers together with you. Not by repeating the MDR basic requirements you’re probably familiar with. We focus on the themes in the MDR where companies still have questions or just need to get more clarity or transparency. This seminar is all about finding answers.

Relevant topics and speakers

We are looking at themes from different perspectives. What legislation or ‘implementing acts’ are yet to come in the next years? What about liability of economic operators? Who is this Person Responsible for Regulatory Compliance? What to expect from Eudamed? What difficulties can you expect on you road to CE re-certification? What about readiness of Notified Bodies? Do you know what an EC Representative stands for?

Program:

9:30 - 9:40 Welcoming

Bart Leekens, Moderator MDR-event 2020 – Allanta

9:40 - 10:00 'Regulations and medical devices'

Carine Vandervorst, Expert Medical Devices Allanta

10:00 - 11:00 'MDR – what’s coming that you cannot read in the regulations, implementing acts'

Valérie Nys, Program Manager - Federal Agency for Medicines and Health Products (FAMHP) - FAGG

11:00 - 11:30 Coffee break

11:30 - 12:30 'An overview of legal liability in the MDR: more of the same or something completely new?'

Sander Briké, Lawyer - Law firm Dewallens & partners

12:30 - 13:30 Lunch break

13:30 - 14:30 'Authorised representatives under MDR'

Sandra Ferretti, EAAR liaison officer and Chief Compliance Officer and Public Affairs Director - Obelis s.a.

14:30 - 15:30 'Materiovigilance: The Belgian competent authorities view'

Christophe Driesmans, Head of the Materiovigilance Entity - DG Post/Vigilance/Materiovigilance - FAMHP - FAGG

15:30 - 16:30 'Notified Body: readiness for MDR and Product CE certification – a bottleneck or an opportunity?’

Bart Mersseman Global Medical Devices Certification Manager - Notified Body SGS Belgium

16:30 - 17:30 Q&A

17:30 - ... Network drink

Audience:

  • manufacturers
  • importers
  • EC Authorised Representatives
  • distributors
  • suppliers & subcontractors within the medical industry

The event focuses on regulatory requirements and is a must for Regulatory Compliance, Quality Assurance & ‘decision-takers’ in companies that place medical devices to the market.

Partners