Registration in the EU

We handle the preparation, review, and maintenance of technical documentation in accordance with EU MDR or IVDR requirements, integrating, where required by the project’s regulatory strategy, the standards for access to other international markets and authorities (FDA, Health Canada, etc.), thereby optimizing regulatory sustainability over time.

The European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) cover new devices and, in some cases, redefine classifications compared to previous directives (software, borderline devices, IVD tests, etc.).

Maytal can support manufacturers of Medical Devices (MDR) and In Vitro Diagnostic Devices (IVDR) in:

• Verifying the MDR and/or IVDR classification of legacy or in-development products

• Creating an adaptation plan for legacy devices requiring certification or reclassification under MDR/IVDR, or defining a suitable regulatory strategy for products in development to ensure timely market entry

• Identifying the applicable standards for their products and the required verification and validation activities

• Developing and compiling the technical documentation needed to demonstrate product compliance, created during the design phase (e.g., software validation, clinical validation, risk management documents, usability validation, etc.), with Maytal experts supporting the manufacturer throughout

• Drafting product technical documentation according to MDR or IVDR, for internal company records and/or submission to the Notified Body for CE certification

• Initiating and managing the certification process with the Notified Body where required, including responding to non-conformities, and supporting certification audits at the company and/or supplier sites

For non-European manufacturers, Maytal can also act as a European Authorized Representative, representing the manufacturer to the authorities and ensuring the confidentiality of technical documentation, without being involved in the commercial process of the products.