Parsek registered as a Medical Device Manufacturer in EUDAMED

Following last year’s medical device registration under Medical Device Directive (MDD) rules and by having our medical device manufacturing system’s quality management process certified under the ISO 13485:2016, we are moving fast toward registering our product under the rules of Medical Device Regulation (MDR)!

We are proud to announce that Parsek is registered as an Economic Operator (EU) in the lately launched EUDAMED module for actor registration! With this important step, we’ve obtained our Single Registration Number (SRN) which opens the doors to all EUDAMED modules as they are publicly available (see more).

EUDAMED is a cross-European medical device interoperable IT system, that will boost transparency and coordination of information regarding medical devices available on the EU market. EUDAMED will act as a registration system for economic operators, a collaborative system between EO and EU Commission, a notification system, a dissemination system and a conformity assessment system.

EUDAMED will gradually deliver various time and cost-saving services such as:

• Checking the declaration of conformity, that is important for distributors, importers, competent authorities and end-users
• A vigilance and traceability lookup service that will deliver access to adverse events
• Quality Management System certificate and proof lookup needed by importers, distributors and other interested parties to gain confidence in the manufacturer capability to deliver quality and safe medical devices
• Information on Clinical Investigation that will enable the interested public to understand better how the intended use of the medical device delivers benefits and what are the risks

Parsek has demonstrated its readiness and commitment to excellence and patient safety by performing the EUDAMED registration on a voluntary basis and will continue to follow this path whenever a new applicable EUDAMED module will be made available.

We aspire that other manufacturers from the region will follow the set example, especially the software medical device manufacturer ones on which the MDR represent a major change.