MTIC InterCert of MTIC Group, has proudly secured the designation for compliance with the Medical Device Regulation (EU) 2017/745 (MDR) from both the Italian Ministry of Health and the European Commission.
In a significant development for the medical device industry, MTIC has been officially designated as a Notified Body (CE 0068) for Regulation (EU) 2017/745, commonly known as the Medical Devices Regulation (MDR). This designation marks a crucial milestone for MTIC, demonstrating their commitment to ensuring the safety, quality, and performance of medical devices in the European market.
The European Union's Medical Devices Regulation (MDR) 2017/745, which came into full effect in May 2021, aims to enhance the safety and effectiveness of medical devices while addressing technological and scientific advancements in the field. The regulation imposes stricter requirements on manufacturers, importers, distributors, and notified bodies involved in the production and distribution of medical devices within the EU.
As a Notified Body (CE 0068) under the MDR, MTIC plays a crucial role in assessing the conformity of medical devices with European regulations. Through conformity assessments, test audits, and the issuance of certificates, MTIC provides manufacturers with a third-party service for assessing compliance with standards and obtaining the CE mark, which allows products to be placed on the European Union market. This designation underscores MTIC's dedication to public health and safety, ensuring access to quality medical devices in the EU market.
This milestone also underscores the importance of collaboration between industry stakeholders, regulators and notified bodies to ensure the effectiveness of medical device regulations and safeguard the health and safety of patients.
In conclusion, the designation of MTIC as a Notified Body for the MDR represents a significant milestone in the regulatory landscape of the European medical device industry. With their expertise, professionalism, and dedication to excellence, MTIC is poised to make valuable contributions to ensuring the safety, quality, and effectiveness of medical devices for patients across the European Union.
Beyond its regulatory role, MTIC boasts an accredited laboratory renowned for its proficiency in testing medical devices for electrical safety, electromagnetic compatibility (EMC), and chemical composition. This amalgamation of regulatory expertise and laboratory excellence positions MTIC at the forefront of ensuring the safety and compliance of medical devices, fostering confidence among manufacturers, healthcare professionals, and patients alike.
Established over half a century ago, MTIC has built a sterling reputation for its commitment to excellence and dedication to ensuring the safety and quality of products in the market. Over the years, the company has acquired several notable designations, including Personal Protective Equipment (PPE), Construction Products Regulation (CPR), safety of toys, machinery, and more. This extensive background underscores MTIC's comprehensive understanding of regulatory requirements and their ability to provide reliable and efficient conformity assessment services across diverse sectors.
On this occasion, we extend our heartfelt gratitude to the diligent team at the Medical Devices Certification Office of MTIC for their unwavering dedication. It is their efforts that have propelled MTIC to become one of the distinguished Notified Bodies for MDR.
We express our sincere appreciation to our customers and partners who have placed their trust in us and collaborated with us throughout this journey.
For in-depth information on MDR and to reach out to our experts, please visit our website or send mail to md@mtic-group.org
