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NDL organiseert webinar ‘New Medical Device Regulations’
8 april -16:00 - 17:00
Free Webinar – 8 April 2021 – 16:00 CET
New MDR regulations will be in place as per May 26th this year. During this one hour webinar on April 8 at 16.00 CET we will focus on how to set-up your organization MDR proof and cost effective in order to continue to have a compliant and agile distribution chain for your medical devices to the European market.
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!