Course description
European Union Medical Device Regulation – EU MDR
In 2017, the Medical Device Regulation (EU MDR) 2017/745 was published, introducing major changes to the previous Medical Device Directive (MDD). Significant changes include device classification, requirements for technical documentation, and clinical evidence, to name a few. To comply with the new EU MDR, medical device manufacturers must plan carefully to ensure the new requirements are fully understood and they identify appropriate resources for full implementation. This on-line computer-based learning course provides comprehensive instruction on the EU MDR. It walks students through every aspect of the regulation and identifying key topics and changes, including the new roles associated with EU MDR; standard requirements that must be met by all manufacturers regardless of class; and the requirements for conformity assessments. The module also provides pre- and post-market requirements of conformity assessment.
Upcoming start dates
Outcome / Qualification etc.
Certificate
By completing/passing this course, you will attain the certificate Medical Device Certificate
Training Course Content
By the end of this course you should be able to:
- Recognize the regulatory background in Europe
- Identify the roles associated with the EU MDR
- Discuss the manufacturing requirements of the EU MDR
- Explain how to comply with pre and post market requirements for conformity assessments.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Reviews
Average rating 5
Great content - the right level of detail without being too overloaded for such a complex regulation. Great job!
Expenses
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.
Very informative, I learnt a lot. It was very heavy and took quite a bit longer than 2 hours.