REGULATORY AFFAIRS CONSULTING
Legacy device on borrowed time? Let’s push it over the finish line.
Have you completed your MDR or IVDR transition?
Do you know the final dates that you can place your devices on the market under the directives?
Have you submitted all of your technical documentation for Notified Body assessment?
We can help you accelerate progress, and complete the transition.
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Commission Implementing Regulation (EU) 2021/607 defined the extension to timelines for MDR.
26 May 2021: All devices not covered by a transitional period must comply with MDR (i.e. new devices).
26 May 2024: Last date to lodge an application with a Notified Body.
26 May 2026: Class III custom-made implantable devices must have a Notified Body certificate.
31 Dec 2027: End of transition period for Class III and Class IIb implantable devices.
31 Dec 2028: End of transition period for Class IIb (non-implantable), Class IIa, Class I sterile, Class I measuring, Class I reusable.
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REGULATION (EU) 2024/1860 defined the transitional extensions.
26 May 2022: All devices not covered by a transition period must comply with IVDR.
26 May 2025: Last date to lodge an application with a Notified Body for Class D devices, and previously certified devices.
26 May 2026: Last date to lodge an application with a Notified Body for Class C devices.
26 May 2027: Last date to lodge an application with a Notified Body for Class B and Class A sterile devices.
31 Dec 2027: End of transition period for Class D devices, and for devices that had a notified body certificate under IVDD (e.g. self-test IVDs).
31 Dec 2028: End of transition period for Class C devices.
31 Dec 2029: End of transition period for Class B and Class A sterile devices.
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You need to carefully check the classification of the device under the directives and the regulations, and compare the routes to conformity.
In the world of non-active devices, Class I Reusable Surgical Instruments are the main example. These devices did not require a certificate under the directives, but do under the regulations.
OUR PEOPLE
Joseph Langley MEng CEng MTOPRA
Design - Manufacturing - Quality - Regulatory - Management
Underpinned by 7 years at a leading notified body.
“Nothing has a higher business case than your MDR or IVDR transition. Without completing it, you face your devices being blocked at customs.”
- Joseph Langley
SERVICES
Every engagement is unique, and we tailor a bespoke set of deliverables to every project.
POTENTIAL PROJECTS
Procedures gap assessment
Technical documentation gap assessment
Project management
Document writing
Training
Clinical requirements
Post market requirements
EXAMPLE DELIVERABLES
Classification rationales
Requirements checklists
Lists of applied standards
Labelling and instructions for use (IFU)
Design control - user needs, design inputs, input/output matrix
Verification & validation planning
Risk management files including risk analysis and benefit-risk analysis
Performance testing protocols and reports
Shelf life testing protocols and reports
Transit testing protocols and reports
Biological evaluation protocols and reports
Clinical evaluation protocols and reports
CMR (GSPR 10.4) justifications
FOR A MORE PREPARED FUTURE
Training:
GSPRs - clause by clause
ISO 14971 risk management
Don’t lose sight of the deadlines.
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Page last updated: July 2026.