MedTech Europe’s Reflection Paper on the terms of MDR Article 18.3

Industry welcomes the use of an implant card (IC) and patient information (so called patient leaflet or brochure) for implantable devices as regulated in Article 18 of the MDR (Regulation (EU) 2017/745). The implant card will contain the key information about the implant and will be a convenient record for the patient. However, the MDR Art.18.3. sets a series of exceptions which are not of immediate general understanding.

With the present paper MedTech Europe intends to give examples of devices which are covered by the terms used in MDR Art.18.3