Medical Device & In Vitro Diagnostic Regulations
The Medical Device Regulation (MDR) 2017/745/EU and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746/EU were published in May 2017, after five years of development. These regulations will replace the three existing medical device directives consisting of the Directive 93/42/EEC on medical devices (MDD), Directive 90/385/EEC on active implantable medical devices (AIMD) and Directive 98/79/EC regarding in vitro diagnostic medical devices (IVDD). The MDR and IVDR impose stricter requirements than the predecessor directives they are replacing, and they will transform the way you do business in the EU.
Thus finding your way through the regulatory medical device landscape can be difficult, because it requires up-to-date knowledge, experience and contacts. Our regulatory team guides you along the most efficient and optimal strategic path to CE-mark, device registration and approval outside EU and support in building up and use post market surveillance.
Regulatory Affairs Services- Medical Devices & IVDS
The areas in which we can make a difference include:
Risk Classification & Technical Files
We perform risk classification of the devices and regulatory pathway with reference to the intended use.
We perform a gap assessment of existing technical documentations that support the safety and performance against the requirements of the applicable regulation (MDR/IVDR). This includes establishment and maintenance of the necessary technical files to support the General Safety and Performance Requirements (GSPR).
Biocompatibility and Toxicological Risk Assessment
We help you bring your device into compliance with the new MDR & IVDR. Perform Biological evaluation Plan, Toxicological Risk Assessment and Biological Evaluation Report. This includes to evaluate changes in regulatory standards.
Clinical Evaluation & Investigations
Managing projects for clinical investigations. Gather and analyse suitable scientific literatures. Prepare the Clinical Evaluation Plan & Report covering all device risk classes. Maintain and update to CER/CEP per MDR.
Risk Management and Risk Analysis
Planning, performing and reporting of Risk Management activities and Risk Analysis of products and processes.
Submissions & Notified Bodies
We manage submission of technical documentation to Notified Bodies and maintain efficient contact with Notified Bodies.
Post Market Surveillance/ Periodic Safety Update Report
We provide advice and support on the establishment and maintenance of Post-Market Surveillance procedures demonstrating the activities of PMS plan, PMS report, PMCF plan and PSU report.
International regulatory projects
We work in Denmark, Sweden, Finland, UK, Ireland, and USA with Medical Devices and in vitro diagnostic medical devices.
Further information regarding services, expertise and how our experience can support your business; please contact us at +4526709648, Email: email@example.com