A full MDR transition will be required by 26 May 2021. This has been ahead of us for quite some time now, but even so there are still some unanswered questions regarding the topic. The webinar ‘The Netherlands as gateway to Europe following the new Medical Device Regulations (MDR) in May 2021’ addresses those questions – and more. During a one hour webinar on 8 April 2021 at 10:00 a.m. EST we will focus on how to set up your organization for MDR in a cost-effective manner so you can continue to have a compliant and agile distribution chain for your medical devices to the European market.
This webinar will be hosted by the HIDC and HealthLink will present alongside our partners MedEnvoy and Emergo by UL.
Webinar Agenda:
Opening by Jelle de Rooij, Holland International Distribution Council
Presentation ‘The EU Authorized Representative; a crucial partner in compliance communication’ by Ronald Boumans, Senior Consultant, Regulatory Affairs at EMERGO by UL
“Competent authorities want to be able to communicate formally with an EU based representative of the manufacturer. This role is done by the EU Authorized Representative. Correct, clear and concise communication is crucial; make sure you select the right partner.”
Presentation ‘The MDR Importer; ensuring compliance when placing devices on the European market’ by Edgar Kasteel, Medenvoy
“The MDR requires verification of devices that will be placed on the European market. Importers and Distributors play a crucial verification role in the Distribution Chain. Non-EU manufacturers need to have agreements in place with and clearly identify their Importer. Make sure you select the right partner as your Importer.”
Presentation ‘The Medical Device Logistic Service Provider; MDR complaint warehousing, logistics and value add service management’ by Kay Bonavita, Vice President of Sales at HealthLink Europe B.V.
“The MDR requires full UDI traceability the moment devices are physically placed on the European market. Mandatory role for the LSP is to provide easy accessible, accurate and secure information of all devices throughout the distribution cycle once physically entering the EU market. Make sure you select the right partner!”
Q&A, moderated by Jelle de Rooij
Click here to register for this event!