Congratulations to our new Mandates for trusting us and being part of Maxcert family Maxcert is representing all these manufacturers from around the world, in case you require any help, feel free to contact us any time. Mandate ID MF… Read More »EUDAMED database – Maxcert
Below you will find a step-by-step implementation guide with regards to the new medical device regulation (MDR EU2017/745). Our guide is simple to understand and will allow you to save time and money when implementing the new regulation.
Easier way to understand the regulatory process for Medical devices Step 1To obtain CE Marking certification, you must comply with European Commission Regulation (EU) No. 2017/745, commonly known as the Medical Device Regulation (MDR). Step 2Appoint a Person Responsible for… Read More »EU MDR PROCESS
Step 1To obtain CE Marking certification, you must comply with European Commission Regulation (EU) No. 2017/745, commonly known as the Medical Device Regulation (MDR). Step 2Appoint a Person Responsible for regulatory compliance. Determine classification of your device using Annex VIII… Read More »The European CE medical device approval process MDR 2017/745
Introduction: The EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) introduce a complete economic operator regime for medical devices. After being approved by the European Council and the European Parliament, in May 2017, the European Medical Devices Regulation (MDR) came into force. MDR implementation is… Read More »Economic Operators for Medical Devices (MDR & IVDR)
The significant changes introduced with the MDR and IVDR regulations have created both a need and an opportunity for RA teams to leverage a better approach to regulatory information management. This explores the new information requirements associated with MDR/IVDR; including… Read More »Why a regulatory information strategy is critical for successful MDR/IVDR transitions?
