STAR7 for the Medical Device Regulation
On 26 May 2022, the new MDR for the medical device sector officially came into force.
Many new and complex procedures have been introduced: among these is the translation of all documentation needed for compliance, as well as the IFUs, into all the official languages of the EU markets.
At STAR7, we’ll help you clear up a few things, putting our experience in the medical sector at your disposal.
Let’s make at least one thing clear from the start: don’t worry, you’re still in time!
Important dates
- 05/05/2017: Official publication of the Regulation
- 26/05/2021: Official date of application of the new MDR and end of the transition period
- 26/05/2022: Official date of application of the new Regulation for IVD devices and end of the transition period
- 26/05/2024: Expiry of the validity of certificates issued according to the MDD and AIMDD Directives. A fundamental date, because it’s the last useful date for adapting your materials, also at the level of translations
- 26/05/2025: Devices with CE marking that comply with the previous Directives can no longer be marketed in Europe
What responsibilities do companies have?
The new MDR requires the translation of all the documentation needed for compliance (operator manuals, sales materials, clinical performance information, software application interfaces, packaging, labelling, etc.), as well as IFUs, into all the official languages of the EU markets in which you distribute your devices.
This is to ensure greater transparency and reliability of information throughout the entire life cycle of medical devices, thus protecting the health and safety of your customers.
All information in the technical documentation must therefore be written so that it’s easy to read and can be clearly understood by the end user, be it a healthcare professional or a customer
How we can support you
Thanks to our network, we are present with our operational offices in nine countries of the European Union, to provide you with a translation validation process directly in the destination country.
Traceability and Transparency are the two assets on which our certification process is based: you can follow every step of validation in real time, through our dedicated tools.
We can also manage all 24 languages required by the MDR, guaranteeing the selection of dedicated teams of translators and reviewers on the basis of each project’s characteristics.
Companies that work with us
