The EU Medical Device Regulation (MDR) replaces the previous Medical Device Directive (MDD), and came into effect 26 May 2021. There are several key differences between the MDD and MDR and we receive questions regularly from manufacturers. Download this free FAQ doc to read this compilation, ...
The MDR and in vitro diagnostic regulation for the EU may seem similar in their structure and chapters, but there are notable differences. The MDR has 123 articles, making it slightly more extensive than the IVDR with 113 articles. The main differences between MDR and IVDR are applicability, p...
The exact differences are laid out therefore; even subtle variances will be caught. Should the current information not be sufficient, this tool will support you to identify and provide the chance to address them quickly. The sooner those gaps are identified, the better. ...
that site will have to address all regulations that govern both drugs and devices. The regulations for each are similar, but not the same for each quality system component. For example, the handling of deviation investigations is different in ...
Review the reasons driving the change from Medical Devices Directive (MDD) to MDR, and when compliance is expected Assess a company’s entities, roles, and device information against major EU MDR requirements to determine compliance Examine quality management system linkages to the regulation, and...
Compared to the previous Medical Device Directive (MDD), the MDR has a wider scope and more stringent requirements. It emphasizes clinical evaluation, post-market surveillance, device traceability, rigorous technical documentation, and risk management. These measures aim to enhance pati...
The new edition of ISO 14971 will continue to be an international standard, and will not address national and regional issues; these will be left up to the national and regional standards bodies. While EN ISO 14971:2012 is harmonized to the MDD, it is not harmon...
Intertek Medical Notified Body Standard Fees (PDF) Please Note If you are a client and have a current MDD certificate(s) with us, these will remain under SEMKO AB NB 0413 until that certificate expires, unless you are specifically notified otherwise. ...
This Excel spreadsheet is designed to support manufacturers making the transition from MDD to MDR. It is specifically designed for the area of MDD “essential requirements” vs. MDR “general safety and performance Requirements” Annex I. This checklist
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