Intertek expands Medical Notified Body scope under EU MDR, offering unrivalled support to medical device manufacturers
15 Jul 2025
New MDR code designations enhance Intertek’s capability to support 2027/2028 compliance deadlines
Sweden - Intertek, a leading Total Quality Assurance provider to industries worldwide, is pleased to announce a significant expansion of the Intertek Medical Notified Body’s designation (EU) 2017/745 Medical Device Regulation (MDR) scope with the addition of 16 new MDR codes.
This strategic scope extension significantly broadens Intertek Medical Notified Body’s capabilities, enabling the assessment and certification of a wider range of medical device technologies and manufacturers under the EU MDR for the very first time. The expanded designation includes active and non-active devices, products incorporating medicinal substances, devices using tissues or cells of human and animal origin, nanomaterial-based devices, Class III custom-made implantable devices, and products without an intended medical purpose as defined in Annex XVI of the MDR.
"With this extension, Intertek Medical Notified Body now holds the largest MDR scope in Sweden, further strengthening our dedication to fostering innovation and upholding patient safety across the European medical device sector," said Curtis Riley, Head of the Intertek Medical Notified Body.
This scope expansion provides new opportunities for medical device manufacturers to access trusted, timely, and comprehensive MDR assessments and certifications. With increased capacity and enhanced technical expertise, Intertek Medical Notified Body is uniquely positioned to help clients successfully navigate the evolving regulatory landscape.
Manufacturers are encouraged to submit applications for MDR certification as early as possible, in advance of the 2027 and 2028 transition deadlines, to maintain uninterrupted market access.
The full scope of designation is available on the EUROPA NANDO website.
For more information or to enquire about MDR certification, please contact IMNB@intertek.com
For Media Information:
Please contact
Lauren Whittemore
VP, Global Strategic Marketing
+1 978 319 8904
Lauren.whittemore@intertek.com
For Technical Information:
Please contact
Curtis Riley
Head of Notified Body
curtis.riley@intertek.com
About Intertek
Intertek is a leading Total Quality Assurance provider to industries worldwide.
Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers' operations and supply chains.
Intertek is a purpose-led company to Bring Quality, Safety and Sustainability to Life. We provide 24/7 mission-critical quality assurance solutions to our clients to ensure that they can operate with well-functioning supply chains in each of their operations.
Our Customer Promise is: Intertek Total Quality Assurance expertise, delivered consistently, with precision, pace and passion, enabling our customers to power ahead safely.
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