Medical Devices Regulation (EU) 2017/745 – MDR

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The MDR is a law that regulates the manufacture, sale and use of medical devices across the European Union (EU). It was passed in 2017 and became applicable in 2021. It aims to protect the health and safety of patients by ensuring that medical devices are safe and effective.

Our MDR Consulting Services ensure full compliance with European regulations MDR 2017/745 for medical devices

A medical device technical file, also known as technical documentation, is a comprehensive collection of documents containing all technical information about a medical device.

A well-documented technical file indicates that the medical device complies with applicable regulatory requirements, such as the European Medical Devices Regulation (MDR).

A compliant medical device technical file is essential for obtaining and maintaining market authorization for the device in the European Union.

The technical documentation for medical devices is a prerequisite for approval before marketing products, except for custom-made products.

CMC will guide you through the CE marking roadmap for medical devices according to the new MDR 2017/745 regulation to ensure compliance and affix the CE Mark on your device.

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Frequently asked questions about Medical Devices Regulation (EU) 2017/745 – MDR

When did the MDR come into force?

The Regulation (EU) 2017/745 on medical devices (MDR) came into force on May 26, 2017. This regulation was designed to modernize and strengthen the regulatory framework for medical devices in the European Union, ensuring a high level of protection for the health and safety of patients and users.

How is the device classification system maintained in the MDR?

The device classification system in the MDR remains relatively unchanged from the MDD, although some new rules have been added to allow for more precise classification based on the level of invasiveness and risk. Devices are classified into different categories (I, IIa, IIb, and III) based on their intended purpose and associated risk, facilitating a more effective assessment of their safety and efficacy.

What must notified bodies do under the MDR?

Notified bodies must be specifically accredited under the MDR to carry out their conformity assessment functions. This means they must demonstrate their capability to conduct rigorous and effective assessments, ensuring that the products they review comply with safety and efficacy regulations.

What is an Authorized Representative, and what are its requirements under the MDR?

Manufacturers of medical devices who are not established in the EU must designate an Authorized Representative in a member state. This representative acts as a liaison between the manufacturer and the EU regulatory authorities. They must meet the updated requirements set by the MDR, which includes having a Person Responsible for Regulatory Compliance (PRRC) who is responsible for ensuring compliance with all applicable regulations.

What implications does the MDR have for medical device manufacturers?

Manufacturers must be prepared to adapt to the new MDR requirements, which include the continuous creation and updating of the Clinical Evaluation Report (CER). Additionally, they must ensure that their technical documentation complies with the MDR requirements and maintain a continuous focus on assessing the safety and efficacy of their products.

What products are considered medical devices under the MDR?

The MDR defines a medical device as any instrument, apparatus, software, implant, reagent, or material intended to be used by humans for specific medical purposes, such as the diagnosis, treatment, or prevention of diseases. This also includes products that do not achieve their primary action by pharmacological, immunological, or metabolic means but may be assisted in their function by such means.

What are the classes of medical devices according to the MDR?

The MDR classifies medical devices into different classes (I, IIa, IIb, and III) based on the associated risk. For example, Class I devices are low risk, while Class III devices are high risk. Each class has different documentation and conformity assessment requirements that manufacturers must meet.

What obligations do manufacturers have regarding post-market surveillance?

Establish and maintain a post-market surveillance system.
Create a Post-Market Surveillance Plan and Periodic Safety Update Report (PSUR).
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Why choose CMC Medical Devices ensure full compliance with European regulations MDR 2017/745 for medical devices?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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