Bart Leekens, Moderator MDR-event 2020 – Allanta
Carine Vandervorst, Expert Medical Devices – Allanta
Valérie Nys, Program Manager – Federal Agency for Medicines and Health Products (FAMHP) – FAGG
At five months before the full implementation of the MDR, what is still to be expected? Which guidance should still be published? How to manage the fact that Eudamed won’t be fully functional ? What are the other obligations for economic operators active in Belgium? What should you be aware of in the national provisions related to the MDR?
Those are some of the questions that the Belgian authority will address to give you a better view of what’s coming that you cannot read in the regulations.
Mrs Nys attained her degree Economics at Louvain School Of Management. She is an experienced program manager with a demonstrated history of working in government administration. She has been working in the health sector in Belgium for 20 years.
Valérie Nys is currently Program Manager at Federal Agency for Medicines and Health Products (FAMHP). She manage the implementation of the new European Regulation for Medical & In Vitro Devices (MDR/IVDR). She a member of a many European workgroups following the implementation of the regulation (steering committee Eudamed, UDI work group, Data exchange WG, MDCG, CAMD operation WG, CAMD transition WG).
Sander Briké, Lawyer – Law firm Dewallens & partners
The current Medical Devices Directive (MDD) already made it possible to hold certain persons liable for non-compliance with the rules. These obligations could however not prevent various scandals from coming to light. Hence, the European legislator considered it necessary to intervene and to tighten the rules with the new Medical Devices Regulation (MDR).
Will the MDR increase the risk of liability? In this presentation we will discuss the liability risk under the MDR and examine to what extent it differs from the MDD.
Sander Briké studied law at the KU Leuven (cum laude) and the Université de Rennes I. Subsequently he worked as an attaché in the diplomatic department of the Belgian embassy in Bangkok. In 2016 he received the postgraduate degree in Health Law and Medical Ethics at the UAntwerpen (magna cum laude).
In 2018 Sander followed with success the “Special Training in Criminal Cassation Proceedings”.
Since February 2015 Sander is member of the Leuven Bar and has joined the law firm Dewallens & partners, a Leuven based law firm specialized in health law, where he is mainly active in the life sciences department.
Sandra Ferretti, EAAR liaison officer and Chief Compliance Officer and Public Affairs Director – Obelis s.a.
The MDR has introduced a new definition and also new requirements concerning Authorised Representatives for medical devices. If in the past, non-EU manufacturers could use their distributors or even grandmother based in the EU to be their EC REP, it is quite clear that this will no longer be possible with the MDR.
You will need to make sure you have appointed the right EC REP, covering the minimum mandate, having the relevant experience and qualification.
Sandra Ferretti is the EAAR liaison officer and Chief Compliance Officer and Public Affairs Director at Obelis, a leading authorized representative based in Brussels. She represents the EAAR at various EUDAMED sub-groups (actors registration, device registration, vigilance, data-exchange), and also now at the MDCG work group on UDI, Vigilance, and IMDRF.
Christophe Driesmans, Head of the Materiovigilance Entity – DG Post/Vigilance/Materiovigilance – Federal Agency for Medicines and Health Products
While the philosophy of the vigilance guidances might be maintained, the exact phrasing of the vigilance obligations in the medical device regulations will have an impact on manufacturers, distributors and importers. The European database Eudamed will play in every aspect of the medical devices including vigilance.
The presentation will try to connect the different obligations to Eudamed, highlight certain vigilance obligation that might have remained hidden in a first reading of the regulations and explain how manufacturers can comply with the vigilance obligations of the MDR if Eudamed is not ready at the date of application. The Belgian national provisions in vigilance are discussed together with certain simple practises and rules the Belgian authority finds key in a good vigilance system.
Graduated as an electromechanical engineer at KUL, Christophe started in July 2014 as assessor of active medical devices at the Federal Agency for Medicines and Health Products (FAMHP) for the materiovigilance entity. Since December 2015 Christophe Is the head of the materiovigilance entity of the FAMHP. In that role he coordinates the tasks of the entity, manages the implementation of various projects assures the realisation of the management plan. He is also responsible for the vigilance aspects of the transition towards the medical device regulations.
Christophe is Belgian’s MDCG vigilance & post-market surveillance and MDCG Nomenclature member. He also represents the competent authorities in the Eudamed vigilance module workgroup. He has been participating in a number of other European working groups that aim to improve and formalize the reporting of vigilance cases and the European cooperation between competent authorities.
Bart Mersseman, Global Medical Devices Certification Manager – Notified Body SGS Belgium
The wildest stories are being told about the progress of MDR and readiness of Notified Bodies and companies. Some are maybe true, many other are based on rumors or even wishfull thinking.
While there are many concerns, different stakeholders are taking actions in order to mitigate risks and to ‘make MDR done’.
In this presentation, we will have a look into the readiness, bottlenecks and opportunities for Notified Bodies and how these aspects can impact companies.
Also some concerns, bottlenecks and readiness of companies will be discussed.
MDR implementation is however not only cumbersome: MDR is drafted in the first place for improving the system, making more robust and by that way also creating opportunities.
Some of these opportunities will also highlighted in the presentation.
If we are all aware of what is going on, preparing what to expect is easier and more focused.
Bart Mersseman attained the degree of electromechanical engineer and a master as biomedical and clinical engineer from Catholic University of Leuven (Belgium).
Qualified later as hospital physicist in the radiotherapy, with a traineeship in the Academic Hospital UZ Leuven, campus Gasthuisberg, and some years of research in the Academic Hospital Gent.
He gained further relevant experience in the field of medical device software and electromedical safety testing in the well-known testing laboratory Cebec.
He is an experienced medical device Lead Auditor and product assessor with a demonstrated history of working in the medical device industry. Skilled in Medical Software, Electromedical testing, Biotechnology, Medical Device Directive/Regulation, Research and Development (R&D), and ISO13485/ISO 14971.
Today, he is working as Certification Manager of the Notified Body SGS Belgium, being responsible form the CE certification of more than 1000 companies worldwide.