EU Regulatory frameworks for medical devices and in-vitro diagnostics are continuously evolving.
A comprehensive understanding of the regulatory requirements plays a key role in providing a successful access to the market.
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.
From the general framework of the EU MDR and IVDR to conformity assessment routes and technical file requirements, our trainings cover a wide range of regulatory topics.
Some examples of our training sessions:
- The EU Market & CE Marking Process
- Technical Documentation – definition & rules,
- Role & definition of EU Authorities, Certification Bodies, Authorised Representatives & the Manufacturer
- Presentation of 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
Our team of lawyers, chemists, pharmacists, and other experts represents the largest centre in Europe for CE Marking and EC REP services. Founded in 1988, Obelis is certified by ISO 9001:2015 and ISO 13485:2016, and partakes in various EU associations and EU commission working groups.
