Although a lot has changed in our worlds since R&Q's December 2019 webinar focused on Solving the EU MDR Labeling Puzzle, the general requirements have stayed the same. In this blog post, our knowledgeable EU MDR regulatory experts sat down to provide some updates on a few more pieces of that labeling puzzle. The European Union Medical Device Regulation (MDR) has enacted some of the most impactful changes in medical device regulation in the past decade. Key provisions within the new regulations specific to labeling present expanded requirements and initiatives towards greater transparency and traceability. The requirements for labeling aren’t relegated to a single section of the EU MDR, but are scattered throughout. This on-demand webinar will help you compile, understand, and learn how to act on those labeling requirements.
R&Q is here to help address any other questions that you may have regarding EU MDR related topics. Contact us today to find out how we can help! If you were not able to attend this webinar, here's a link where you can sign up to view the on-demand version (and download the slides).
Q: Do we need to translate information on product labels into EU languages?
A: Yes, anything that falls under Section 23 of Annex I must be provided in the official language determined by the Member State. Only languages for the MS in which the product is sold are required.
Q: What are your thoughts regarding a sterile medical device having packaging with a dual sterile barrier. Is the expectation that both the primary sterile barrier packaging and the secondary sterile barrier packaging display the respective sterile barrier system symbol, or can the secondary sterile barrier show the double sterile barrier system symbol while the primary sterile barrier packaging remains blank? This question also assumes no other labeling content is contained on the inner packaging (which represents the primary sterile barrier for the product).
A: It is sufficient to have only the secondary sterile barrier show the symbol.
Q: If my medical device does not fall under the e-IFU (electronic Instructions For Use) directive, does it mean I still need to upload the user manual into the company web site?
A. Yes, relevant information must be reproduced on a website if the company has one.
Q: Can you tell us if we need to add the CE mark and EU Rep on the outer shipping package or just on the device?
A: Must be affixed on both the device and the relevant packaging.
Q: I could not find any information on the MD symbol, where can I find information on the MD symbol?
A: Please see MedTech Europe's "Use of Symbols to Indicate Compliance with the MDR" guidance document, which can be found here.
Q: Can we make our own symbols and add in a symbol table in our IFU (Instructions For Use) to eliminate text that has to be translated in the IFU?
A: Yes, medical device manufacturers can create their own symbols as long as they are translated. It is best to use harmonized symbols as much as possible, though.
Q: Is it permissible to include abbreviated instructions for reprocessing with the product and full instructions on the company website?
A: Full instructions must be provided with the product in the IFU if a paper IFU is provided with the product because it needs to be representative of the full process needed to reprocess the device.
Also, In MDR 23.1, a company has to have their IFU on the website (if they have one) but has to meet the criteria in 207/2012 To replace paper with electronic. Even if that isn’t your intention, there are still sections of 207 that you should consider (Article 9). One of the statements from that section is:
“Instructions for use in electronic form which are provided in addition to complete instructions for use in paper form shall be consistent with the content of the instructions for use in paper form.” (COMMISSION REGULATION (EU) No 207/2012)
Q: How can we register our companies & products if EUDAMED is delayed two years?
A: Device manufacturers can postpone their entering of data into EUDAMED. All applicable data, however, must be entered within 18 months after the application of EUDAMED.
Q: What are the labeling requirements for Importer/Distributor and who is responsible for updating the labeling, Legal Manufacturer, or Importer/Distributor?
A: The Legal Manufacturer is responsible. The importer label with their name and address may be applied by the importer when the product reaches the European Union. That label must appear on the product before the customer receives the product.
Q: Does the MDR introduce or specify any Unique Device Identification (UDI) rules for the European market?
A: Every device will have to be assigned an UDI. The manufacturer must obtain an UDI code from a UDI supplier, upload device-specific data into EUDAMED, and then link the UDI to that data set. After that, the UDI must be placed on the medical device label before distribution can occur. Keep in mind, though, that there are some differences between the FDA and the EU MDR UDI.
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1) MedTech Europe. Use of Symbols to Indicate Compliance with the MDR. Published 06 May 2019. Accessed 29 July 2020. https://www.medtecheurope.org/resource-library/use-of-symbols-to-indicate-compliance-with-the-mdr/
2) Official Journal of the European Union. COMMISSION REGULATION (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices(Text with EEA relevance). Published 09 March 2021. Accessed 29 July 2020. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32012R0207&from=EN#d1e529-28-1