ACIG

ENGLISH 24 This takes account of the current lack of notified bodies and additionally does away with differential treatment in relation to higher risk classes. Manufacturers of class I medical devices according to the currently applicable MDD that will have to be allocated to a higher class under the MDR rules may (assuming MDD conformity) continue to be marketed until 26. May 2024. This applies to, among other things, reusable surgically invasive devices that come under (the new MDR) class Ir (Annex VIII, 5.2, Rule 6, second bullet point MDR) for which a declaration of conformity has been created in accordance with the MDD prior to 26. May 2020. This does away with the “final deadline” up to May of 2020 for the devices mentioned in Article 120(3). Dr. Wolfgang Sening: “This was an important step in ensuring that existing de- vices, such as surgical instruments, can still be sold based on the previous regu- latory conditions and will be a source of relief for clinics and hospitals worried about supply shortages.” One drawback: Should a material change (impact on compliance) be made to a device (brought to market under the MDD) after the date of application of the MDR, the modification and conformity are to be assessed according to the MDR rules, even during the extended transitional period. Unique device identification (UDI) The statutory regulations of the FDA and the new MDR requiring that all medical devices be labelled pose a further challenge. Reusable surgical instruments have their UDI carrier on the device itself. It is important that the UDI carrier be placed in such a manner that it can be read throughout the entire lifetime of the device, even if it is subjected to cleaning, disinfection and potentially sterilisa- tion. The data is stored in the UDI database. Access is provided via the UDI-DI. The durability of the UDI / data matrix code affixed to the medical device must be verified in relation to the reconditioning cycle during the specified lifetime of the device. To this end, regulatory issues and durability tests have already been discussed and conducted by us with many clients. As a result, an increasing number of surgical instruments are subjected to a defi- ned cleaning and sterilisation cycle as a means of verifying the UDI code’s durabi- lity (based on EN ISO 15883 and ISO 17665). From 26. May 2019, the GS1 (Global Standards One), HIBCC (Health Industry Business Communications Council) and the ICCBBA (International Council for Commonality in Blood Banking Automation) will serve as assigning bodies for UDI until the Commission has designated assig- ning bodies. UDI carriers will be mandatory for reusable surgical instruments from 26. May 2027 (in the case of class I devices).