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MDR 2017/745 Transition Timelines Explained

The document outlines the timeline and key deadlines for the transition to Medical Device Regulation (EU) 2017/745, which was adopted on April 5, 2017, and initially set to become mandatory on May 26, 2020, but was postponed to May 26, 2021, due to the Covid pandemic. It specifies that certain medical devices, particularly Class I and custom-made implantable Class III, must comply by the new deadline. The document emphasizes understanding the transition period and prioritizing products for certification.

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4 views8 pages

MDR 2017/745 Transition Timelines Explained

The document outlines the timeline and key deadlines for the transition to Medical Device Regulation (EU) 2017/745, which was adopted on April 5, 2017, and initially set to become mandatory on May 26, 2020, but was postponed to May 26, 2021, due to the Covid pandemic. It specifies that certain medical devices, particularly Class I and custom-made implantable Class III, must comply by the new deadline. The document emphasizes understanding the transition period and prioritizing products for certification.

Uploaded by

AR
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd

MDR

Regulation
2017/745
Timelines

Martin J Conneely
Learning Objectives
• Understand the timeline associated with the transition of MDR
2017/745.
• Understand which devices take priority.

Martin J Conneely
Article 120

Transitional Provisions
Martin J Conneely
Medical Device Regulation (EU) 2017/745.
Timelines.
• Adopted April 5, 2017 and published in the Official Journal of the
European Union May 5, 2017.
• The regulation came into force on May 25 2017.
• This is the norm once it is published in the Official Journal of the
European Union it comes into force 20 days later.
• MDR was to become mandatory on May 26, 2020.
• On April 23rd 2020 the EC pushed out the date of the MDR 2017/745
to May 26th 2021 due to the Covid pandemic.
• Postpone the application date by 1 year.

Martin J Conneely
Martin J Conneely
Deadlines for certain classification
Two transition dates.
• “Have to happen” by the 25th May 2021 and the 2nd date has a
“transition period”
• Lets clarify the former term.
• Some products have to be compliant with the MDR 2017/745 by the
26th May 2021.

Martin J Conneely
Which product need to meet the 26th May
2021 Deadline?
• Class I. • Self Certification
• Class I r. • New classification.
• New products within scope. • New classification.
• Custom made implantable Class • New classification.
III.
• Certificates expire by 25th May • Need to follow MDR
2021

Martin J Conneely
What have we learned
• We understand the transition period for the MDR 2017/745.
• We understand the deadline for products to achieve certification
• We understand which products should be prioritised.

Martin J Conneely

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