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MDCG Guidance on MDD Certificates and SSCP under the MDR

Important Notice, News in Brief

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Important Notice, News in Brief

Guidance on Person Responsible for Regulatory Compliance

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Unique Device Identification (UDI) and Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics

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Device Registration and Legacy Devices

News on Brexit

New Guidance for the UK Responsible Person Published

September 26, 2019

United Kingdom (UK) to Request ‘UK Responsible Person’

August 19, 2019

Details about the Regulation of Medical Devices in Case of No-Deal Brexit

February 28, 2019

Brexit Key Challenges – a Brief Case Study

February 15, 2019

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New Notified Bodies Designated under the MDR and IVDR

October 15, 2019

News from the Commission – Notified Bodies and a Potential MDR Extension for Selected Devices

September 4, 2019

European Commission Website on Regulations MDR / IVDR Restructured

August 21, 2019
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mdi Europa specializes on the services of an EU Authorized Representative*, but we also provide a worldwide network of highly experienced consultants and experts on regulatory affairs. Translations, market research,… Read More

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Meet mdi Europa at Medica and Arab Health

Meet mdi Europa at Medica mdi Europa will attend Medica from November 18 to 20, 2019. Please contact us if you wish to schedule a meeting. Contact team mdi Europa… Read More

Important Notice

MDCG Guidance on MDD Certificates and SSCP under the MDR

Manufacturers of medical devices are eagerly waiting for more guidance on the implementation of the MDR. MDCG has now issued a useful guidance on the Summary of Safety and Clinical… Read More

Important Notice, News in Brief

European Commission Website on Regulations MDR / IVDR Restructured

The European Commission has restructured and further developed its website on the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). We strongly… Read More

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If you raise a wonderful child – would you lay its destiny in the hands of someone who isn’t loyal? We wouldn’t! As a family owned business with a moving… Read More

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Complete Link Section mdi Europa

The section below is intended for all parties who are involved in the manufacturing of medical devices including in vitro diagnostic medical devices. You will find an up to date… Read More

CE Marking, Download Section Service, Guidance Documents, IVDR Service, Legislation Documents, Library, MDR Service

Complete Download Section mdi Europa

The section below is intended for all parties who are involved in the manufacturing of medical devices including in vitro diagnostic medical devices. You will find more than 20 important… Read More

Important Notice, News in Brief

Guidance on Person Responsible for Regulatory Compliance

The Medical Device Coordination Group (MDCG) has recently published a useful guidance on the “Person Responsible for Regulatory Compliance” (PRRC) according to article 15 of the MDR and IVDR. There… Read More

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