ENSURE A SMOOTH
MDR TRANSITION
WITH PRO-LIANCE
MDR DEADLINE
The deadline is coming closer - therefore, your activities for the MDR transition remain very urgent! From the outset PRO-LIANCE has continuously expanded its team with top experts who are able to provide you with advice and support.
Florian Tolkmitt talks to Monir El Azzouzi from Easy Medical Device on how to secure business under MDR
GETTING THE FACTS RIGHT
MDR deadlines and requirements
MDR Application
The transition application, including MDR-compatible QM documentation and a submission plan of technical documentation to the Notified Body, must be submitted by May 26, 2024.
Notified Bodies strongly recommend to submit applications as early as possible to ensure that the conformity assessment procedure can be completed before the end of the transition period.
MDR Contract
A contract with the Notified Body must be signed by September 26, 2024.
The contract determines when the technical documentation must be submitted to the Notified Body. It aims to ensure sufficient time for review and, if necessary, the correction. Late or delayed submissions carry a high risk that timely CE marking will not be possible.
Certification
Device certification under MDR for legacy devices must be completed before December 31, 2027 for Class III devices and implantable Class IIb devices and before December 31, 2028 for other devices, except custom made class III implants and for Annex XVI products.
This implies that manufacturers must submit their Technical Documentation early enough, so that the Notified Body can perform the review and potential nonconformities can be closed.
It is essential to plan your submissions realistically. For many devices approximately 12-18 months will be needed for review and corrections after submission.
To determine your real submission-dates use the following simplified method:
December 31 (2027/2028) – 18 months = latest submission date
Now distribute the number of devices you have accross the time between the latest submission date and the earliest realistic time you can be ready with the first Technical Documentation. This should give you an even distribution of workload over the next months and years.
Need assistance with your submission?
HOW WE CAN ASSIST YOU
This is our 5-point plan for your smooth MDR transition.
1
Process optimization
We assist in making your processes and QM system compliant with the MDR requirements.
2
Analysis & strategy
We help identify gaps in your technical documentation and plan activities to close them.
3
Timing
Together we develop a realistic schedule for closing the gaps and completing the technical documentation(s).
4
Support
We provide support during conformity assessment procedure by responding to queries from the Notified Body.