EU Medical Device Regulatory Affairs explained Simply

How to get approval to sell Medical Devices within the European Union. Understand regulatory affairs & ISO 13485 2016

Ratings 4.56 / 5.00

EU Medical Device Regulatory Affairs explained Simply

What You Will Learn!

Understand how Medical Device Regulation works in the European Union.
Differentiate between a regulation and a directive.
Steps required to gain permission to manufacture and sell a medical device in the European Union.
Explain the roles and responsibilities of a Competent Authority & a Notified Body with regard to European Union regulation.
Understand in simple terms the Active Implantable Medical Device Directive 90/385/EEC.
Understand in simple terms the Medical Device Directive 93/42/EEC.
Understand in simple terms the In Vitro Diagnostic Medical Device directive 98/79/EEC
Understand the difference between the directives and the new Medical Device Regulation, MDR EU 2017/745(MDR) & EU 2017/746 (IVDR).
How to obtain CE Marking.
Classification of medical devices in the European Union.
What part does ISO 13485 2016 play in the European Union regulation system.
Understand the part that Manufacturer, the Authorized representative and the EFTA play in the European Union regulation system.
Brexit understand the impact to the European Union regulation.
Understand the transitional time lines from the directives to the medical device regulation.
Understand regulatory affairs

Description

Each lecture is explained in simple format. If the student takes each lecture step by step, they will understand how a company gains permission to manufacture a medical device which will be allowed to be sold in Europe. This module is ideal for a person who wants to work in medical device regulation, who wants to be involved in a medical device start up or who wants to be involved in the medical device industry either in operations, quality, engineering, marketing and research/development. If you are a student who wants to understand the rules that govern the sale of medical devices in the European Union Market place this course is perfect for you. If you are a medical device manufacturer outside the European Union and would like to sell your product in Europe this course is ideal for you. You will understand how important the ISO 13485 2016 standard is to gain market approval.

The following topics will be covered:

´Difference between Regulation and a Directive.
´Steps required to get permission to manufacture and sell a medical device in Europe.
´Competent authority
´Notified body.
´MDD 90/385/EEC Active Implantable Medical Device Directive.
´MDD 93/42/EEC Medical Device Directive.
´MDD 98/79/EEC The directive of In Vitro Diagnostic Medical Devices .
´MDR EU 2017/745(MDR) & EU 2017/746 (IVDR).
´CE Marking approval process.
´Classification of medical device. Including the MDR 2017 745 classification.
´ISO 13485 2016
´Other players the Manufacturer, the Authorized representative and the EFTA.
Each lecture has a quiz that will enable students to understand the learner outcomes
Brexit understand the impact to the European Union regulation.
Understand the transitional time lines from the directives to the medical device regulation.