Medical Device Arrangement Services

The safety and quality of medical devices is increasingly important as consumers demand the highest safety standards from suppliers of products and services in the healthcare industry. In addition, international rules and regulations for medical device manufacturers are becoming more and more complex and stringent. 

Devices become more innovative and vulnerable to privacy and security threats. In May 2017, the new Medical Devices Directive (MDR) came into force, replacing the existing Medical Device Directive (93/42 / EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385 / EEC) (AIMDD). As of May 26, 2021.

The new Regulation focuses on clinical performance, better traceability of medical devices, and greater transparency for patients. Access to the European market for medical devices will become stricter, and also requirements for manufacturers, importers and distributors and Notified Bodies will be expanded and strengthened. The purpose of the regulation is to ensure better protection of public health and patient safety.

Medical device manufacturers have a responsibility to keep end users safe. Therefore, they must comply with European regulations to ensure that their innovative and constantly improved devices are safe and perform well. EUROLABis designed to review the compliance of products with the essential requirements of the MDD (Medical Device Directive) for access to the EU market.

• EUROLAB There are two Notified Bodies for the EU Medical Device Directive (2017/745, MDR): EUROLAB Certification GmbH (NB 0124) and EUROLAB Certification BV (NB 0344).
• With the combination of these notified bodies EUROLABcontinues to be a reliable, competent partner for its customers in the field of medical device certification and will also offer comprehensive services in the future.

Medical device manufacturers must navigate a complex landscape of regulatory requirements before selling their products in international markets. They must ensure that their products comply with relevant international standards and regulations.

EUROLAB It is active almost everywhere in the world, and members of our medical device certification team have broad expertise in a wide range of medical and in vitro diagnostic devices.

EUROLAB, with its highly expert team and internationally accredited laboratories, Medical Device Arrangement Services It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.