Intertek Receives Medical Device Regulation (MDR) Designation
MDR is a new set of regulations for the manufacturing of medical devices in the EU.
May 15, 2020
Stockholm, Sweden - Intertek, a leading Total Quality Assurance Provider to industries, is pleased to announce that the Intertek Medical Notified Body AB (IMNB) has been designated against MDR 2017/745 from the Swedish Competent Authority.
On May 5, 2017, the European Union adopted the new Medical Devices Regulation (MDR), which will replace both the Medical Devices Directive and the Active Implantable Medical Devices Directive by May 26, 2021. Intertek will begin accepting applications from medical device companies for MDR certification, which now includes:
- Stricter control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts in the EU
- Reinforcement of the criteria for designation and processes for oversight of Notified Bodies
- Inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
- Improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on unique device identification
- An “implant card” containing information about implanted medical devices for a patient
- Reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for the authorisation of multi-centre clinical investigations
- Strengthened post-market surveillance requirements for manufacturers
- Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance
Calin Moldovean, President of Business Assurance and Food Services said, “We are honoured to receive the MDR designation from the Swedish Competent Authority. Intertek aims to provide total quality assurance to all its clients, and this designation brings us into the future of medical device audits. Our global Intertek Medical Notified Body team has worked hard on achieving this designation, and we look forward to helping our medical device customers with their transition to MDR.”
For information on how to apply to IMNB for MDR certification visit intertek.com/assurance/mdr-designation.
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Director, Global Marketing Intertek Business Assurance
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Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 46,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.