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.

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/IVDR). This includes establishment and maintenance of the necessary technical files to support the General Safety and Performance Requirements (GSPR).

Biocompatibility and toxicology

We help you bring your device into compliance with the new MDR & IVDR. Perform Biological evaluation Plan, Toxicological Evaluation and Biological Evaluation  Reports. This includes to evaluate changes in regulatory standards.

Clinical plan & investigations

Managing projects for clinical investigations. Gather and analyse  suitable scientific literatures. Prepare the Clinical Evaluation Reports and develop procedures to compile  the clinical evaluation reports.

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: info@slet-dette.toxregulatoryaffairs.com