We are happy to announce that Transcutan has received CE approval for the T-port™ Enteral Access System, according the European Commission Regulation (EU) No. 2017/745), commonly known as MDR. This means the T-port™ can continue to be sold for clinical use within the EU, which is good news for Parkinson patients that have been waiting for this aid.
The EU Medical Device Regulation (MDR) has high demands for quality and safety for medtech products, which is a big challange for many companies in the industry. With this CE-mark Transcutan AB is one of the first companies in Europé to comply with MDR´s highest standard, Risk Class III implantable.