EU CE Mark
The European Union consists of 28 member states that mandate CE Marking for medical devices. Additionally, three countries—Norway, Iceland, and Liechtenstein—though not EU members, are part of the European Economic Area (EEA) and thus also require CE Marking. Switzerland, while neither an EU member nor an EEA signatory, has adopted the Medical Devices Directives into its national legislation, necessitating CE Marking for medical devices sold within its borders. We offer assistance in obtaining CE Marking, enabling you to market your medical device in any of these European jurisdictions.
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The CE marking is must for a medical device intended to market in the European Union. The CE marking shows that the product complies with EU safety, health and environmental requirements and meets the General Safety and Performance Requirements (GSPR). The manufacturer must identify most suitable Medical Device Regulations (MDR 2017/745) and harmonised standards applicable to their device. It is the responsibility of a manufacturer to conduct Conformity Assessment, Technical File compilation, EU Declaration of Conformity and place the CE marking on the device.
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Technical Documentation
The Technical Documentation must be submitted to the Notified body to review as part of conformity assessment to ensure the medical device meets the safety and performance requirements. The Technical Documentation must include product specific requirements/ testing, appropriate conformity assessment route, Clinical Evaluation, Risk Assessment and the information regarding the quality system.
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Post-Market Surveillance and Vigilance
Regulators in most medical device markets require registrants to meet post-market surveillance (PMS) obligations to maintain compliance. However, PMS rules can vary between different medical device markets, requiring manufacturers to develop tailored rather than one-size-fits-all approaches.
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Vigilance requirements under EU Medical Device Regulation (MDR) No. 2017/745 and In Vitro Diagnostic Device Regulation (IVDR) No. 2017/746 mandate notification and evaluation of serious incidents and field safety corrective actions (FSCAs) for medical devices and in vitro diagnostic devices, posing challenges for regulatory professionals due to uncertainties surrounding reporting specifics. Non-compliance with vigilance reporting can result in significant penalties, necessitating proactive engagement from Regulatory Affairs (RA) professionals to ensure accurate and timely reporting of incidents and FSCAs.
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EU MDD to MDR Gap Assessment
Performing a gap assessment from Medical Device Directive (MDD) to Medical Device Regulation (MDR) is a crucial step for companies in the medical device industry. This process ensures that the transition from the old regulatory framework (MDD) to the new one (MDR) is smooth and that the company complies with the latest regulatory requirements. Purpose of gap assessment aims to identify areas where the current processes and documentation may not align with current MDR requirements.
We conduct a thorough review of existing documentation, including technical files, quality management system, risk management documents and post market reports to ensure that it meets the requirements of MDR. We provide a detailed analysis of each identified gap, including its potential impact on compliance and patient safety. Prepare and submit necessary documentation to regulatory authorities and interact with the notified bodies to ensure alignment and compliance to regulations.