Medical Device Regulation (MDR)

TRACOE medical GmbH has already met the key requirements

In recent months, the topic "MDR" has often been the subject of discussion in many professional bodies and trade and professional associations. The MDR sets out the new regulations for the development, manufacture and distribution of all medical devices throughout Europe and entered into force on the 25th of May this year. The new rules will be fully effective following a transition period of 3 years, i.e. in May 2020.

As a developer and manufacturer of medical devices and appliances for patients, who have had a tracheotomy or larynx surgery, TRACOE medical GmbH has already given some considerable thought to this subject in advance:

  • Indeed we see the MDR as a demanding change, but, with our many years of quality consciousness, we will rise to and successfully overcome the challenge. Patient safety is the focus of the MDR and is central to our efforts too.
  • Yes, the requirements will increase. All market players will be affected: manufacturers, retailers, users and patients. We anticipate that small manufacturers, in particular, will struggle to meet the requirements of the MDR and there will be a change in the market.
  • Our products have demonstrated their clinical effectiveness over many years and are of high quality. We already meet the essential requirements of the MDR, e.g. the so-called UDI (unique device identifier). With additional innovations in mind, we benefit from our many years' experience with quality management, which we had already built up in the past.
  • In order to implement all the new requirements of the MDR promptly, we have established sustainable activities in close cooperation with our Notified Body. These are bundled in a project that reports directly to the management.
  • We have sufficient knowledge, experience and capacity available to implement all the requirements without disrupting the normal business operations.

TRACOE medical is therefore well prepared and thus expressly welcomes any measures serving the quality and safety of medical devices, in accordance  with our guiding principle: quality, made by people for people.