What many may already have expected has now been confirmed. UK Prime Minister Boris Johnson has been forced by the House of Commons to request another delay of Brexit date… Read More
Month: October 2019
Performance Evaluation for IVD Medical Devices
Performance evaluations will take an integral part in the CE Marking process of in vitro diagnostic medical devices under the In Vitro Diagnostic Medical Devices Regulation (IVDR). This article outlines,… Read More
Guidance on Qualification and Classification of Software under the MDR and IVDR Published
The Medical Device Coordination Group (MDCG) has published a long awaited guidance document in October on the qualification and classification of software under Regulations (EU) 2017/745 and 2017/746 on medical… Read More
The Regulatory Affairs Network That Keeps Your Business Safe
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
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
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
New Notified Bodies Designated under the MDR and IVDR
MedTech industry is desperately waiting for more Notified Bodies to be designated under the MDR and IVDR. Two more organizations have now been appointed. You may already have heard the… Read More