The MDR brings many challenges for medical device manufacturers. Certainly, an area that requires increased attention and careful planning is labeling.
Section 23 of annex I of the MDR defines the General Safety and Performance Requirements (SPR) for labels and instructions for use. Depending on the intended use of a device, numerous changes may need to be implemented under the MDR – compared to the MDD.
Below is a non-exhaustive list of elements that should be considered
- If a website exists, manufacturers must make available and keep up-to-date the instructions for use (IFU) and related information on that website,
- contrary to the MDD, the MDR clearly requires that the details of the EU Auth. Rep. must be included on the label,
- labels must indicate blood and tissue derivatives,
- labels must indicate CMR or endocrine-disrupting substances,
- the UDI is a new element that must be reflected on the label,
- if there is no expiry date, the date of manufacture has to be reflected,
- warnings and precautions must appear on the labels,
- an indication that the product is a medical device is required to appear on the label,
- the IFU must contain information about residual risks.
In case you need to know more on labeling changes
For related information about labeling changes please also check our topics as linked below. If you have any specific questions or require assistance for compliance of your labels and IFU, please don’t hesitate to get in touch with us.