European Representative Medical Devices

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Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national …

European Authorized Representative for …

https://www.emergobyul.com/services/european-authorized-representative-medical-device-and-ivd-companies

Your European Authorized Representative serves as a liaison between you and the national Competent Authorities (Ministries of Health). Additionally, your appointed …

European Authorized Representative - Wikipedia

https://en.wikipedia.org/wiki/European_Authorized_Representative

Authorised Representatives – The European Union …

https://eumdr.com/authorised-representatives/

A change of authorised representative requires a proper agreement that defines the arrangements between the manufacturer and both the outgoing and the new authorised …

Authorised Representatives, Importers and Distributors - Public …

https://health.ec.europa.eu/medical-devices-new-regulations/getting-ready-new-regulations/authorised-representatives-importers-and-distributors_en

The Regulations clarify the respective responsibilities of authorised representatives, importers and distributors, as well as the tasks that could be delegated by the legal …

European Authorized Representative (EC Rep) - I3CGLOBAL

https://www.i3cglobal.com/eu-representative/

According to the EU MDR 2017/745 and IVDR 2017/746, EU Representative is mandatory for Non-European manufacturers wishing to sell medical devices and (IVDs) on the …

List of European Authorised Representative …

https://www.compliancegate.com/european-authorised-representative-companies/

Obelis Group. Headquartered in Brussels, Belgium, Obelis Group was founded in 1988, and today specializes in offering European Authorised …

Authorised Representative Medical Devices - Easy Medical Device

https://easymedicaldevice.com/authorised-representative-medical-devices/

Easy Medical Device is a company that has offices in EU, UK and Switzerland and can act as Authorized Representative and Importer. This helps you avoid having to appoint …

New European MDCG Guidance on Medical Device Vigilance …

https://www.emergobyul.com/news/new-european-mdcg-guidance-medical-device-vigilance-requirements

The long-awaited Medical Device Coordination Group (MDCG) Guidance on Vigilance has been published to the European Commission website. MDCG 2023-3, …

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