Trainings for Manufacturers
Explore Our Information Platform
MDlaw.eu is the regulatory information platform on medical devices and in vitro diagnostics medical devices. The platform is an indispensable tool for manufacturers to stay up to date about the latest regulatory updates and have all necessary documents on MDR and IVDR at one place.
MDlaw.eu is also the place where you will find answers to your questions and doubts about the compliance process in the European Union and United Kingdom.
Experience Our In-House Trainings
Understand the general framework of the EU MDR and learn about classification rules, conformity assessment routes and technical file requirements. Address the essential requirements for in-vitro diagnostic devices and guarantee CE-marking of your devices under the EU IVDR. Please find below some examples of our training sessions:
- The EU Market & CE Marking Process
- Technical Documentation– definition & rules,
- Role & definition of EU Authorities, Certification Bodies, Authorized Representatives & the Manufacturer
- Presentation of MDD & MDR– essential safety requirements & conformity assessments
- Introduction to MDR– scope, timeframe & differences with MDD
- MDR Classification Rules
- Clinical data & Post Market Surveillance
- Requirements for EUDAMED & UDI