Medical Device Regulation (MDR)
The Medical Device Regulation (MDR) 2017/745/EU replaced the medical device directives consisting of the Directive 93/42/EEC on medical devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMD).
The MDR imposes stricter requirements than the predecessor directives and 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
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.
Technical files
We perform a gap assessment of existing technical documentations that support the safety and performance against the requirements of the applicable regulation MDR. 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 requirements: Perform Biological evaluation Plan, Toxicological Risk Assessment and Biological Evaluation Report, as well as chemical characterization. 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 CEP/CER 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.