At MTIC InterCert, we take pride in offering comprehensive and efficient Medical Device Certification Services. Our dedicated team of experts is committed to guiding you through the complexities of complying with the European Medical Device Regulations (MDR). With extensive knowledge and experience, we're here to ensure that your medical devices meet the necessary standards for market access in the European Union.

Even several years after the introduction of the new European Medical Device Regulations (EU) 2017/745 (MDR), manufacturers and distributors continue to face challenges in adapting to the updated requirements as they transition from previous guidelines to the new regulatory framework.

In essence, all new medical devices introduced to the European market after May 26, 2021, must comply with the provisions of the MDR.

Our experts at MTIC InterCert have conducted comprehensive assessments of the changes within the MDR. We have a global presence and are readily available in your region. As a Notified Body designated for conducting conformity assessments under the MDR, we are fully prepared to evaluate your quality management system and review your technical documentation.

As a member of the NB Team, MTIC participates in the technical working tables and is always updated on regulatory developments and guidelines applicable to medical devices.

MDR Transition Period Extended

On March 15, 2023, the European Parliament approved a proposal aimed at alleviating the challenges faced by medical device manufacturers. With this latest extension of the Medical Devices Regulation EU 2017/745, manufacturers now have the option to apply for an extension of the transition period for their products.

This new regulation is expected to come into effect shortly upon publication in the European Journal. Manufacturers will have the opportunity for the following extended transition periods:

• May 26, 2026, for custom-made medical devices and Class III devices.
• December 31, 2027, for higher-risk non-exempted Class IIb implants and Class III devices.
• December 31, 2028, for low-risk medical devices.

It's important to note that manufacturers must demonstrate that they have already taken steps to transition to the new regulations to be eligible for the extension. We offer our support to all manufacturers seeking a professional and reliable Notified Body to address the challenges posed by the MDR. Please feel free to reach out to us.

Why Choose MTIC InterCert

At MTIC InterCert, we offer:

• Internationally recognized training courses to help you understand the new requirements.
• Assistance in confirming that your products meet MDR requirements.
• Up to date MDR certification to ensure EU market access.
• We understand the complexities and challenges that come with EU MDR compliance and provide the expertise you need for a smooth certification process.

Our Services

Our services focus on the transition period and the timeline for compliance with MDR 2017/745. Our experts can assist you in meeting deadlines and addressing all issues relevant to maintaining access for your Active and/or Non-active medical devices to European markets.

MTIC provides a comprehensive service for the certification of medical devices in accordance with Article 52 of the MDR, depending on the risk class of the medical device (Class I sterile, Class I with measuring function, Class I reusable, Class IIa and Class IIb).

After identifying the certification procedure from Annexes IX (Chapters I, II, and III), X, and XI (Part A and Part B) of the MDR, the manufacturer can request a quote from MTIC by filling out form F-PC-MDR-04-01 and sending it to md@mtic-group.org

The list of devices and related conformity assessment procedures according to MDR for which MTIC is notified can be found here

The conditions for certification activities according to MDR are described in RG-PC-MDR-01-01

Beyond its regulatory role, MTIC InterCert 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 InterCert at the forefront of ensuring the safety and compliance of medical devices, fostering confidence among manufacturers, healthcare professionals, and patients alike.

For further details on test services you can visit our webpage:

Price List

You can access a summary of our standard pricing for conformity assessment activities right here.

Get in Touch

We encourage you to reach out to us to learn more about the specifics and timing of MDR 2017/745 and how it affects your business. Our team is here to provide you with the guidance and support you need to navigate the ever-evolving landscape of medical device regulations.