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MedTech Europe updates MDR symbols guidance

  • Posted by: inetika
  • Category: GLOBAL NEWS

The pan-European industry association MedTech Europe has updated guidance first published in May 2019 relating to the requirements in the Medical Devices Regulation (MDR, 2017/745) for new symbols to indicate specific characteristics of the devices concerned.

The guidance was initially issued to provide advice while the applicable international standard, ISO 15223-1, went through the revision process to include many of the new symbols. With the publication of ISO 15223-1:2020 expected during this year, MedTech Europe has decided to update its initial advice, using the symbols included in the DIS version of the standard, as some adjustments have been made from the designs reported previously.

MedTech Europe comments that:

“These symbols can be used internationally. They must be described in the Instructions for Use in line with the MDR 23.1. h) until they are published in a harmonised standard. Note, that jurisdictions outside of the EU may have different requirements regarding the ‘Information to be Supplied by the Manufacturer’.

When using the template provided in the annex:

  • If some of the symbols are not needed for your particular needs, you can drop all or some of the symbols from the list but MedTech Europe asks you to keep always the same order as shown on the attached listing. Using always the same order by the manufacturer will speed up user recognition and acceptance of the symbols and their meaning.
  • Please make sure you always use the same titles as given in the attached template (to avoid any confusion amongst users).”

Copies of the new guidance can be accessed from here.