MDR stands for Medical Device Regulation. It is the European Union’s new medical device regulation, which has applied since 26 May 2021. The MDR aims to raise the safety, performance and quality standards of medical devices.

MDR certification is a document showing that a medical device meets the requirements of the MDR. This document is required for a medical device to be placed on the European Union market.

The MDR certification process

The MDR certification process consists of the following stages:

  1. Selecting a notified body: MDR certification is carried out by a notified body designated under the MDR. Notified bodies are authorised to assess whether devices conform to the MDR requirements. Class I devices that are not sterile, have no measuring function and are not reusable surgical instruments do not need a notified body; the manufacturer declares conformity itself.
  2. Conformity assessment: Under the conformity assessment procedure chosen for the device’s class, the notified body assesses the quality management system and the technical documentation against the MDR requirements.
  3. EU certificate and declaration of conformity: If the assessment is successful, the notified body issues the EU certificate; the manufacturer then draws up the EU Declaration of Conformity and affixes the CE marking. These steps are required for the medical device to be placed on the European Union market.

Requirements for MDR certification

For MDR certification, the medical device must meet the following requirements:

  • Safety: The medical device must not endanger the safety of users and patients.
  • Performance: The medical device must fulfil its intended purpose.
  • Quality: The medical device must meet consistent quality standards throughout the manufacturing process.

Benefits of MDR certification

MDR certification offers medical device manufacturers the following benefits:

  • Access to the European Union market: An MDR certificate is required for medical devices to be placed on the European Union market.
  • Competitive advantage: An MDR certificate gives medical device manufacturers a competitive advantage.
  • Credibility: An MDR certificate shows that the medical device meets the safety and performance requirements.

How is MDR certification obtained?

You can follow the steps below for MDR certification:

  1. Determine your device’s class and the conformity assessment route that applies, then choose a suitable notified body.
  2. Start the application process with the notified body.
  3. Bring your medical device into line with the MDR requirements.
  4. Take part in the conformity assessment carried out by the notified body.
  5. Obtain your EU certificate, draw up the EU Declaration of Conformity and affix the CE marking.

MDR certification is a complex and time-consuming process. Working with an experienced notified body is therefore recommended.

Isn’t there an easier way to do this?

The requirements above may have intimidated you. There are many points to pay attention to. If you wish, we at MedENvolve can manage this process on your behalf, and like the other companies that trust us, you too can obtain your CE certificate. Our team in İzmir is ready to help you.

In this article, we have tried to answer the following questions:

  • What is MDR?
  • The MDR certification process
  • Requirements for MDR certification
  • Benefits of MDR certification
  • How is MDR certification obtained?
  • İzmir CE – MDR & IVDR Certification

For any other questions, you can reach us through our contact page.