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Medical Device Regulation (MDR) - basics

The Medical Device Regulation (EU) 2017/745 (or simply MDR) plays a central role in the regulation of medical devices within the EU. It sets standards for safety and performance and aims to ensure that medical devices meet the needs of patients while minimising risks. Compliance with the MDR is essential for manufacturers looking to market their devices in the EU.


What is MDR?

The MDR is a set of mandatory regulatory guidelines established by the European Union and having force of law in the EU. It replaces the Medical Device Directive (MDD) and places greater emphasis on patient safety, transparency, and traceability throughout the entire lifecycle of a medical device.

Why is MDR so Important?

MDR is of great importance in the field of medical devices in the EU as it significantly elevates the standards for patient safety and product quality. It mandates rigorous clinical evaluations, post-market surveillance, and comprehensive technical documentation for all types and classes of devices. This heightened scrutiny aims to bolster public confidence in medical devices while prioritising patient well-being.

Is compliance with MDR mandatory?

MDR is not a set of flexible guidelines; it is a binding legal framework that does not leave much room for compromise. It is mandatory for any entity wishing to engage with the EU medical device market. It is a legal and regulatory obligation that carries significant consequences for non-compliance, making adherence to the regulation imperative for manufacturers and stakeholders in the medical device industry.

Where can I find MDR?

The official text of the MDR can be found on the website of the European Comission. It provides the complete and authoritative version of the regulation, along with any amendments or updates that may have been made.

What does MDR have to do with CE-Marking?

MDR plays a central role in the process of CE-marking, which signifies compliance with EU regulations. CE-marking is a declaration by the manufacturer that their medical device meets all relevant requirements outlined in MDR. It grants access to the EU market, demonstrating that the device adheres to the highest standards of safety and performance. MDR outlines how CE-marking is obtained and maintained.

How is MDR Arranged?

MDR is structured into 10 chapters, each covering different aspects of medical device regulation. These chapters address general provisions, obligations of economic operators, identification and traceability of devices, requirements for clinical evaluation and investigations, conformity assessment procedures, requirements for post-market surveillance and vigilance, classification rules, specific obligations for certain devices, EU database on medical devices (EUDAMED), and final provisions. Each chapter is further divided into articles detailing specific requirements and provisions. The articles of the MDR are elaborated upon in 17 annexes, providing detailed requirements and specifications.

What is certification under MDR?

Certification under the Medical Device Regulation refers to the process by which a notified body, which is a specialised third-party organisation designated by an EU member state, assesses and verifies that a medical device complies with the requirements outlined in the MDR. Certification confirms that the device meets the necessary standards for safety, quality, and performance, allowing it to be legally placed on the market within the European Union.

Certification under the Medical Device Regulation is mandatory for medical device classes higher than class I that are intended to be marketed and used within the EU. It is a legal requirement that manufacturers must comply with to demonstrate that their devices meet the safety, quality, and performance standards outlined in the MDR.

What are Common Specifications?

Common specifications, in the context of medical device regulation, refer to mandatory standardised requirements and criteria that must be met by medical devices to ensure their safety, quality, and effectiveness. These specifications are set forth in separate documents referred to as Common Specifications. They are commonly recognised and accepted within the regulatory framework and are essential for achieving regulatory compliance. They provide a consistent and standardised basis for evaluating and assessing medical devices. Common specifications can cover a wide range of aspects, including design, manufacturing, testing, labeling, clinical evaluation, and post-market surveillance.

Waht are Harmonised Standards?

Harmonised standards are technical guidelines recognised by the EU that provide a presumption of conformity with certain aspects of MDR. These standards, when followed, simplify the process of demonstrating compliance. They cover a wide range of topics, including quality management, risk management, and specific requirements for different types of medical devices. Contrary to Common Specifications, Harmonised Standards are not mandatory.

Bottom line

MDR represents a monumental shift in the regulation of medical devices within the EU. It places patient safety at the forefront and raises the bar for transparency, accountability, and quality in the industry. Understanding and adhering to MDR requirements is essential for manufacturers looking to bring their medical devices to the EU market.

What do you need to have to succeed in certification and sell your products in the EU:

Notified body
certificate
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Basic UDI

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EUDAMED registration
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We are ready to become your EC REP

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What you need to know to succeed in certification and sell your products in the EU:

CE-marking process under MDR

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CE-marking process under IVDR

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MDR Checklist
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Medical Device Regulation (MDR) - basics

The Medical Device Regulation (EU) 2017/745 (or simply MDR) is a complex and comprehensive document, and it plays a central role in the regulation of medical devices within the EU. It sets high standards for safety and performance and aims to ensure that medical devices meet the needs of patients while minimizing risks. Compliance with the MDR is essential for manufacturers looking to market their devices in the EU.


What is MDR?

The MDR is a set of regulatory guidelines established by the European Union to ensure the safety, quality, and performance of medical devices. It replaces the Medical Device Directive (MDD) and places greater emphasis on patient safety, transparency, and traceability throughout the entire lifecycle of a medical device.

Why is MDR so Important?

MDR is of great importance in the field of medical devices in the EU as it significantly elevates the standards for patient safety and product quality. It mandates rigorous clinical evaluations, post-market surveillance, and comprehensive technical documentation. This heightened scrutiny aims to bolster public confidence in medical devices and facilitate innovation while prioritizing patient well-being.

Is compliance with MDR mandatory?

MDR is not a set of flexible guidelines; it is a binding legal framework that leaves no room for compromise when it comes to the safety, quality, and performance of medical devices. It is mandatory for any entity wishing to engage with the EU medical device market.

Compliance with the MDR is mandatory to safeguard patient safety, uphold quality standards, and maintain the integrity of the medical device industry within the EU. It is a legal and regulatory obligation that carries significant consequences for non-compliance, making adherence to the regulation imperative for manufacturers and stakeholders in the medical device industry.

Where can I find MDR?

The official text of the MDR can be found on the website of the European Comission. It provides the complete and authoritative version of the regulation, along with any amendments or updates that may have been made.

MDR and CE-Marking

MDR plays a central role in the process of CE-marking, which signifies compliance with EU regulations. CE-marking is a declaration by the manufacturer that their medical device meets all relevant requirements outlined in MDR. It grants access to the EU market, demonstrating that the device adheres to the highest standards of safety and performance.

How is MDR Arranged?

MDR is organised into several key sections, each addressing specific aspects of medical device regulation. These sections cover a wide range of topics, including general safety and performance requirements, clinical evaluations, post-market surveillance, and more. This structured approach ensures that all critical aspects of medical device development and deployment are properly addressed.

Here's an overview of the key types of information you can find in the MDR:

  • The MDR begins with definitions and the scope of the regulation, outlining which products are considered medical devices and the criteria for classification.
  • GSPR provides essential safety and performance requirements that medical devices must meet. These include requirements related to risk management, design and manufacturing, clinical evaluation, labeling, and post-market surveillance.
  • The MDR outlines different conformity assessment procedures based on the risk class of the device. It explains the steps and requirements for obtaining CE marking.
  • Information on how to obtain CE marking for medical devices, indicating compliance with EU regulations.
  • Requirements for clinical evaluations, including the use of clinical data to demonstrate safety and performance. Details on clinical investigations are also provided.
  • Requirements for creating and maintaining technical documentation for medical devices. This includes information on the design, manufacture, and performance of the device.
  • The MDR outlines requirements for ongoing post-market surveillance activities, including reporting adverse events and maintaining vigilance.
  • Information on how regulatory authorities monitor the market for non-compliant devices and take corrective actions.
  • Details on the role of Notified Bodies, which are third-party organisations designated to assess the conformity of medical devices.
  • Requirements for the use of UDI, a system that provides a unique identifier for each medical device to enhance traceability.
  • Information on the roles and responsibilities of manufacturers, authorised representatives, importers, and distributors./li>
  • Requirements for collecting, evaluating, and reporting clinical data for medical devices, including the preparation of CERs.
  • Guidelines for conducting clinical investigations and performance studies to generate clinical evidence.
  • Ethical considerations and patient confidentiality in the context of clinical investigations.
  • Detailed rules for classifying medical devices based on their intended use and potential risk.
  • Information on the transition from the previous Medical Device Directives (MDD) to MDR.
  • Requirements for reprocessing single-use medical devices.
  • Reference to harmonised standards that provide a presumption of conformity with the regulation.
  • Additional detailed information, including specific requirements for different types of medical devices.

What is certification under MDR?

Certification under the Medical Device Regulation (MDR) refers to the process by which a notified body, which is a specialised third-party organisation designated by an EU member state, assesses and verifies that a medical device complies with the requirements outlined in the MDR. Certification confirms that the device meets the necessary standards for safety, quality, and performance, allowing it to be legally placed on the market within the European Union (EU).

Certification under the Medical Device Regulation is mandatory for medical device classes higher than class I that are intended to be marketed and used within the European Union (EU). It is a legal requirement that manufacturers must comply with to demonstrate that their devices meet the safety, quality, and performance standards outlined in the MDR.

Common Specifications

Common specifications, in the context of medical device regulation, refer to mandatory standardised requirements and criteria that must be met by medical devices to ensure their safety, quality, and effectiveness. These specifications are set forth in separate documents referred to as Common Specifications. They are commonly recognised and accepted within the regulatory framework and are essential for achieving regulatory compliance. They provide a consistent and standardised basis for evaluating and assessing medical devices. Common specifications can cover a wide range of aspects, including design, manufacturing, testing, labeling, clinical evaluation, and post-market surveillance.

Harmonised Standards

Harmonised standards are technical specifications and guidelines recognised by the EU that provide a presumption of conformity with certain aspects of MDR. These standards, when followed, simplify the process of demonstrating compliance. They cover a wide range of topics, including quality management, risk management, and specific requirements for different types of medical devices.

Bottom line

MDR represents a monumental shift in the regulation of medical devices within the EU. It places patient safety at the forefront and raises the bar for transparency, accountability, and quality in the industry. Understanding and adhering to MDR requirements is essential for manufacturers looking to bring their medical devices to the EU market and ensure the highest standards of healthcare delivery.

Further reading

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