Notice - an Applus+ Company
Founded in 2015 under the name of Notice and headquartered in Istanbul, the company became part of Applus+ Laboratories, a division of the Applus+ Group, in July 2025. As a Notified Body for medical devices under the EU Medical Device Regulation (MDR) EU 2017/745, Notice - an Applus+ Company helps manufacturers demonstrate conformity with EU requirements, enabling timely access to the European market.
Accreditations for Notice - an Applus+ Company
Notice is accredited by TÜRKAK under EN ISO/IEC 17021-1 for the certification of medical device quality management systems. It is also designated as a Notified Body (NB2764) under EU 2017/745 (MDR) for a wide range of medical devices. These credentials underscore the organisation's commitment to the highest standards of quality and competence in medical device certification.
Services Offered by Notice - an Applus+ Company
Notice offers a comprehensive suite of services dedicated to the conformity assessment and certification of medical devices. Its core mission is to guide manufacturers through the complex regulatory landscape, ensuring their products and systems achieve full compliance with both the EN ISO 13485 standard for quality management and the EU Medical Device Regulation (MDR).
Quality Management System Certification
Notice conducts conformity assessments of EN ISO 13485 quality management systems, confirming that manufacturers meet the requirements for consistent and compliant processes throughout a device's lifecycle. The full scope of accreditation can be found on the TÜRKAK website.
MDR Conformity Assessments
Notice provides comprehensive conformity assessment services under the EU MDR 2017/745. The organisation is authorised to perform assessments based on Annex IX (Chapter I and II), which covers quality management systems and technical documentation, and Annex XI (Part A), which covers production quality assurance.
The scope of its designation is extensive, covering a wide variety of medical technologies. This includes numerous types of active medical devices, such as those for monitoring vital signs, utilising non-ionising radiation, and software-driven devices.
It also encompasses a broad range of non-active medical devices, including cardiovascular and orthopaedic implants, dental materials, and non-active instruments.
Furthermore, we possess horizontal technical competence for specialised areas such as devices combined with medicinal substances, devices supplied in a sterile condition, and reusable surgical instruments, ensuring a holistic assessment approach.
