CE Marking 93/42/EEC
and the new MDR
2 day course

Course Outline
Every medical device you place on the market in the EU must have a CE mark – it’s a mandatory legal requirement. You probably know that already, but are you sure you are fully up to date with all the regulatory requirements and standards involved, especially in the current changing regulatory environment? Would you benefit from a refresher on CE marking coupled with a deep dive into the new Medical Device Regulation to understand the impact this could have on both new and already marketed Medical Devices?

This course provides a working understanding of the major features of the Medical Devices Directive and comparisons to the new Medical Device Regulation, including terminology, product classification, conformity assessment routes, and Technical Files, including the Essential Requirements and will look at the significant changes on the horizon. As well as guiding you through the Medical Device Directive, it brings you up to scratch with all the other relevant legislation you need to understand, including the new Medical Device Regulations and the implementation timelines.

Topics covered include

  • Brief history of the directives
  • Notified Bodies & Competent Authorities Harmonised standards
  • Medical Device Directive 93/42/EC
  • Active Implantable Medical Devices 90/385/EEC
  • In-vitro Diagnostic Devices 98/79/EC
  • Product Classification
  • Conformity Assessment Routes
  • Contents of a Technical File
  • Risk Management
  • Clinical Evaluation
  • Labelling
  • Vigilance
  • Post Market Surveillance
  • What will change with the New Medical Device Regulations

Outcomes

  • An appreciation, knowledge and understanding of the main requirements of the directives
  • An understanding of the additional requirements for your quality management system
  • Understand the role of regulatory bodies
  • Mechanisms for determining device classification
  • Awareness of compliance routes, based on device classification
  • Outline of Technical File requirements
  • Integration of Risk Management throughout
  • Post production obligations
Connect with us

Toll free 1-877-623-8742 or 317-706-1493

Maetrics Ltd
Blenheim Court
Huntingdon Street
Nottingham
NG1 3BY
United Kingdom (UK)

Nottingham/Europe HQ +44 115 921 6200

Basel +41 61 511 4930

For questions regarding Maetrics services, please email information@maetrics.com.