How to Apply for MDR Certification
Intertek Medical Notified Body is a designated notified body for medical devices under MDR 2017/745 and is accredited for ISO 13485 certification. We deliver an efficient certification process focused on supporting compliance while keeping patient safety at the forefront.
Application process – MDR
In the table below, we describe, step by step, what the MDR application process involves, what you need to do and what you can expect from us.
| 1. PRE-APPLICATION | 2. FORMAL APPLICATION | 3. QUOTATION AND AGREEMENT |
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During the pre-application phase, you are asked to provide basic information about your company and your products by completing the following pre-application form. |
Based on the information provided in the pre-application you will be asked to provide further information via our Client Information Form (CIF) and Device List. It is important that all information provided at this stage is accurate and complete to enable an efficient review of the application and a smooth compliance assessment process. |
Intertek Medical Notified Body (IMNB) will draw up and send a quotation for MDR services relating to conformity assessment, based on the information provided. If you choose IMNB as your notified body for MDR assessment, an agreement must be signed and returned before the application process can continue. By signing the quotation, you confirm that the details of the legal entity, including the registered address, and the scope of the proposed certification are correct. Any changes made after the quotation has been signed will be handled in accordance with the applicable change management process. |
Who can apply for certification to MDR?
Our current MDD clients and new clients can apply. Before submitting your application, please ensure the codes covering your products are part of our scope of designation. We handle products across all risk classes, including Is, Im, Ir, IIa, IIb and III, for our approved codes. More detailed information about scope of designation can be found at the NANDO website.
Already certified and considering changing your Notified Body? If you already hold certification with another Notified Body, our team can support a smooth transition. Certificates can be transferred at any stage of the certification cycle. Learn more about the process on our page: Choosing the Right Notified Body.
General Overview of the Certification Process
