THE DEADLINE IS NEAR

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.

MDR – THE GREAT MISSUNDERSTANDING

Florian Tolkmitt zu Gast bei Easy Medical Device: Wie Sie sich jetzt auf die MDR-Transition vorbereiten können.

GETTING THE FACTS RIGHT

MDR Deadlines and requirements

Application

The transition application, including MDR-compatible QM documentation and a timetable for submission(s) of technical documentation to the Notified Body, must be submitted by May 26, 2024.

Notified Bodies strongly recommend submitting applications as early as possible and submitting technical documentation(s) as quickly as possible to ensure that the conformity assessment procedure can be completed before the end of the transition period.

Contract

A contract must be signed with the Notified Body by September 26, 2024.

The timetable & contract determines when the technical documentation must be submitted to the Notified Body. These must ensure sufficient time for review and, if necessary, the correction of deviations.
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. For many devices approximately 12-18 months will be needed for this after submission.

Be careful and plan your submissions realistically. Latest submission date = Dec-31 MINUS 18 months. BUT (!) This should not be your submission deadline, because Notified Bodies will not be able to handle all remaining Technical Documentations reviews at the same time. In order to secure your MDR-CE mark, you should submit AS EARLY AS POSSIBLE

Need assistance with your MDR Transition?

Contract

A contract must be signed with the Notified Body by September 26, 2024.

The timetable & contract determines when the technical documentation must be submitted to the Notified Body. These must ensure sufficient time for review and, if necessary, the correction of deviations.
Late or delayed submissions carry a high risk that timely CE marking will not be possible.

Need assistance with your MDR contract?
GET IN TOUCH

Contract

A contract must be signed with the Notified Body by September 26, 2024.

The timetable & contract determines when the technical documentation must be submitted to the Notified Body. These must ensure sufficient time for review and, if necessary, the correction of deviations.
Late or delayed submissions carry a high risk that timely CE marking will not be possible.

Need assistance with your MDR contract?
GET IN TOUCH

Contract

A contract must be signed with the Notified Body by September 26, 2024.

The timetable & contract determines when the technical documentation must be submitted to the Notified Body. These must ensure sufficient time for review and, if necessary, the correction of deviations.
Late or delayed submissions carry a high risk that timely CE marking will not be possible.

Need assistance with your MDR contract?
GET IN TOUCH

The transition application, including MDR-compatible QM documentation and a timetable for submission(s) of technical documentation to the Notified Body, must be submitted by May 26, 2024.
A contract must be signed with the Notified Body by September 26, 2024.
The timetable (and contract) determines when the technical documentation must be submitted to the Notified Body.
Notified Bodies will not accept timetables that provide for submissions at the end of the transition period to ensure sufficient time for review and, if necessary, the correction of deviations.
Notified Bodies are already planning capacity for the entire transition period to counteract resource constraints at the end of the period.

Notified Bodies strongly recommend submitting applications as early as possible and submitting technical documentation(s) as quickly as possible to ensure that the conformity assessment procedure can be completed before the end of the transition period.
Late or delayed submissions carry a high risk that timely CE marking will not be possible.
This means that manufacturers must work at full speed on implementing the requirements, even if the extension of the transition period provides some breathing room, to ensure that the documentation is MDR-compliant and that the conformity assessment procedure under the MDR can begin in a timely manner. This way, the scarce resources of the Notified Bodies can be used to prevent the scenario announced for 2024, where products disappear from the market due to lack of certification, from being simply postponed for a few years.

THE DEADLINE IS NEAR

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.

Application Deadline

The transition application, including MDR-compatible QM documentation and a timetable for submission(s) of technical documentation to the Notified Body, must be submitted by May 26, 2024.

Do you need help with the application?
GET IN TOUCH

Contract Deadline

The timetable & contract determines when the technical documentation must be submitted to the Notified Body. These must ensure sufficient time for review and, if necessary, the correction of deviations.

Do you need help with the application?
GET IN TOUCH

Contract Deadline

The timetable & contract determines when the technical documentation must be submitted to the Notified Body. These must ensure sufficient time for review and, if necessary, the correction of deviations.

Do you need help with the application?
GET IN TOUCH

Application Deadline

The transition application, including MDR-compatible QM documentation and a timetable for submission(s) of technical documentation to the Notified Body, must be submitted by May 26, 2024.

Do you need help with the application?
GET IN TOUCH

Contract Deadline

The timetable & contract determines when the technical documentation must be submitted to the Notified Body. These must ensure sufficient time for review and, if necessary, the correction of deviations.

Do you need help with the application?
GET IN TOUCH

Contract Deadline

The timetable & contract determines when the technical documentation must be submitted to the Notified Body. These must ensure sufficient time for review and, if necessary, the correction of deviations.

Do you need help with the application?
GET IN TOUCH

The transition application, including MDR-compatible QM documentation and a timetable for submission(s) of technical documentation to the Notified Body, must be submitted by May 26, 2024.
A contract must be signed with the Notified Body by September 26, 2024.
The timetable (and contract) determines when the technical documentation must be submitted to the Notified Body.
Notified Bodies will not accept timetables that provide for submissions at the end of the transition period to ensure sufficient time for review and, if necessary, the correction of deviations.
Notified Bodies are already planning capacity for the entire transition period to counteract resource constraints at the end of the period.

Notified Bodies strongly recommend submitting applications as early as possible and submitting technical documentation(s) as quickly as possible to ensure that the conformity assessment procedure can be completed before the end of the transition period.
Late or delayed submissions carry a high risk that timely CE marking will not be possible.
This means that manufacturers must work at full speed on implementing the requirements, even if the extension of the transition period provides some breathing room, to ensure that the documentation is MDR-compliant and that the conformity assessment procedure under the MDR can begin in a timely manner. This way, the scarce resources of the Notified Bodies can be used to prevent the scenario announced for 2024, where products disappear from the market due to lack of certification, from being simply postponed for a few years.

Klinische Bewertung

Bei der Klinischen Bewertung sammeln, beurteilen und analysieren wir die klinischen Daten Ihres Medizinproduktes. So werden die Sicherheit, Leistung und der klinische Nutzen Ihres Medizinproduktes belegt.

direkt zum Service

Klinische Bewertung

Bei der Klinischen Bewertung sammeln, beurteilen und analysieren wir die klinischen Daten Ihres Medizinproduktes. So werden die Sicherheit, Leistung und der klinische Nutzen Ihres Medizinproduktes belegt.

direkt zum Service

Klinische Bewertung

Bei der Klinischen Bewertung sammeln, beurteilen und analysieren wir die klinischen Daten Ihres Medizinproduktes. So werden die Sicherheit, Leistung und der klinische Nutzen Ihres Medizinproduktes belegt.

direkt zum Service

MDR Application Deadline

The transition application, including MDR-compatible QM documentation and a timetable for submission(s) of technical documentation to the Notified Body, must be submitted by
May 26, 2024.

Notified Bodies strongly recommend submitting applications as early as possible and submitting technical documentation(s) as quickly as possible to ensure that the conformity assessment procedure can be completed before the end of the transition period.

Need assistance with your MDR application?
GET IN TOUCH

MDR Contract Deadline

A contract must be signed with the Notified Body by
September 26, 2024.

The timetable & contract determines when the technical documentation must be submitted to the Notified Body. These must ensure sufficient time for review and, if necessary, the correction of deviations.
Late or delayed submissions carry a high risk that timely CE marking will not be possible.

Need assistance with your MDR contract?
GET IN TOUCH