What is EU MDR/IVDR?
These new regulations are designed to increase traceability of devices placed on the market. Additional content needs to be included on device packaging and labelling including a Unique Device Identifier (UDI), new symbols and warning statements. Device attributes also need to be submitted to a new database (EUDAMED) facilitating device and manufacturer traceability.
How does Kallik help with EU MDR?
Kallik helps medical device manufacturers ensure their products are correctly labelled in accordance with new MDR requirements for device identification, manufacturer, safety and re-use requirements
Key points
- Minimizes the impact of transitioning towards MDR compliant labelling by optimizing available label real estate
- Establishes a single source of labelling 'truth' that all market-facing product information and materials flow from
- Ensures alignment and traceability of content shared across IFU’s and printed labels reducing risk of discrepancies and simplifying transition toward e-labelling (eIFU's)
Timeline of Updates
May 2017: MDR & IVDR Enter Into Force
Medical Devices Regulation (MDR) 2017/745 and In Vitro Diagnostics Regulation (IVDR) 2017/746 replace existing EU directives MDD, AIMDD and IVDD. The new regulations are legally binding and require all products sold into the EU to carry a Unique Device Identifier (UDI) and new symbology on product and packaging labels.
May 2020: MDR Date of Application
The date from which MDR requirements other than EUDAMED reporting come into force including approval of designated notified bodies, device and manufacturer documentation, conformity assessments, certifications and timelines for device labeling.
May 2021: Class III Medical Devices Need to Carry the UDI on the Label
Packaging and labelling for devices that typically sustain or support life must now carry the device UDI in both machine and human readable forms, details of the nominated EC representative and be identified as a medical device using the approved EU symbol.
May 2022: EUDAMED Launch (new date, was May 2020)
The European Database for Medical Devices, or EUDAMED, is the database that will be used to monitor the safety and performance of devices under the new Medical Devices Regulation (MDR) and In Vito Device Regulation (IVDR). The two year delay to the implementation does not impact timescales for device labelling.
May 2022: Device Registration
18 month window opens for registration of all classes of medical and In Vitro devices with the EUDAMED database. Commencement of registration delayed by two years from May 2020 due to unavailability of EUDAMED.
May 2023: Class II a/b Medical Devices Need to Carry the UDI on the Label
Packaging and labelling for devices that are temporarily installed within the human body must now carry the device UDI in both machine and human readable forms, details of the nominated EC representative and be identified as a medical device using the approved EU symbol.
May 2023: Class D In Vitro Devices Need to Carry the UDI on the Label
Packaging and labelling for In Vitro devices that present a high risk (e.g. HIV blood diagnostic test) must now carry the device UDI in both machine and human readable forms, details of the nominated EC representative and be identified as a medical device using the approved EU symbol.
May 2025: Class I Medical Devices Need to Carry the UDI on the Label
Packaging and labelling for devices that present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages And must carry the device UDI in both machine and human readable forms, details of the nominated EC representative and be identified as a medical device using the approved EU symbol.
May 2025: Class B/C In Vitro Devices Must Carry the UDI on the Label
Packaging and labelling for In Vitro devices that present a medium risk (e.g. blood glucose self-testing) must now carry the device UDI in both machine and human readable forms, details of the nominated EC representative and be identified as a medical device using the approved EU symbol.
May 2027: Class A In Vitro Devices Must Carry the UDI on the Label
Packaging and labelling for In Vitro devices that present a low risk (e.g. specimen receptacles) must now carry the device UDI in both machine and human readable forms, details of the nominated EC representative and be identified as a medical device using the approved EU symbol.
How to be compliant
Establish a global source of labeling truth backed up by digital signatures and comprehensive audit trails that all market-facing product information and materials flow from to deliver process transparency and simplify proof of compliance.
Eliminate multiple siloed systems by moving to a centralised cloud-based solution will improve visibility, control and co-ordination making it easier to identify and updated impacted labels whilst demonstrating compliance
Reduce the cost of printing and distributing multiple-language printed IFUs and booklets by posting these to the website as eIFUs whilst ensuring accurate correlation between printed and electronic content.
Unite dispersed teams and eliminate disjointed processes resulting from use of spreadsheets, documents, emails and localised desktop solutions that otherwise make identification of all impacted labels an almost impossible task.
Be prepared for further global roll-out of UDI and the anticipated need for product serialization by using EU MDR as an opportunity to get ahead of the market by transforming your labeling processes now.
Ensure information conveyed in both human and machine readable Device and Production Identifiers on product and package labeling is accurate and aligned with content in readiness for future submission to EUDAMED