Medical Devices EU-MDR: Compliance with EU Medical Device Regulations

What is Medical Devices EU-MDR?

EU-MDR: Key Features and Changes

The EU-MDR introduced significant changes compared to the previous MDD (Medical Device Directive). These changes include stricter regulations, particularly in areas such as clinical data, post-market monitoring, traceability and product classifications.

• Scope Expansion: The EU-MDR covers not only traditional medical devices, but also software-based medical devices (e.g. mobile health apps) and aesthetic devices. There are more safety and quality requirements for these devices.
• Risk Classification: Significant changes have been made to risk classification. More products are now classified as high risk and more stringent controls are required for these devices.
• Clinical Data Requirement: More detailed clinical data requirements have been introduced to prove the efficacy and safety of devices. Comprehensive clinical testing and evaluations must be carried out before products are placed on the market.
• Clinical Monitoring and Post-Market Surveillance: The EU-MDR requires increased traceability and strengthened post-market surveillance systems once products are on the market.
• Traceability (UDI) : TheUnique Device Identification (UDI) system ensures the traceability of devices. A unique identification number is assigned to each medical device, which makes it possible to trace the entire life cycle of the device.
• Notified Bodies: Medical device manufacturers are required to obtain certificates from notified bodies in order to place their products on the market. These organizations oversee the safety, efficacy and regulatory compliance of products.

EU-MDR Compliance Process: Steps for Medical Device Manufacturers

There are certain steps that medical device manufacturers must follow to comply with the EU-MDR. These steps are critical to ensure the safety of products, verify compliance with regulations and obtain CE marking.

a. Product Classification

The EU-MDR classifies medical devices into different classes according to their risks and intended use. The product class determines the requirements that must be complied with:

• Class I: Low-risk devices (e.g. bandages and syringes).
• Class IIa and IIb: Medium-risk devices (e.g. some surgical devices and diagnostic tests).
• Class III: High-risk devices (e.g. pacemakers and implants).

Each class has different requirements. More clinical data and audits are required for high-risk devices.

b. Technical File Preparation

A detailed technical dossier should be prepared for each medical device. This file should include the design, manufacture, risk assessments and clinical data. The technical dossier is reviewed by the notified body and used to verify the safety of the device. The technical dossier is a key document for compliance with the EU-MDR.

c. Clinical Evaluation

Clinical evaluation is required to verify the efficacy and safety of medical devices. The EU-MDR makes it mandatory to prove the performance and safety of devices based on clinical data.

• Clinical Data Collection: Clinical data is collected to verify the effectiveness of the device. This data can be obtained from clinical tests, literature reviews or clinical trials.
• Clinical Performance: For high-risk devices, clinical testing and performance data are scrutinized in more detail and stringently.

d. Quality Management System (QMS)

ISO 13485 is an international standard for the quality management system (QMS) that medical device manufacturers must establish. This system covers all processes from the design and manufacture of devices to after-sales monitoring. The EU-MDR requires manufacturers to establish and implement this quality management system.

e. Audits and Certification

Notified bodies audit the quality management systems of medical device manufacturers and the conformity of their products. This audit is carried out to obtain CE marking. The CE marking indicates that the product can be sold safely on the European Union market. The certification process is more detailed and comprehensive for high-risk devices.

Tips for Compliance with EU-MDR

a. Early Planning

Early planning is necessary to comply with the EU-MDR. Manufacturers should take the necessary steps prior to the design of their devices, taking into account the requirements of the regulations.

b. Adequate Clinical Data

Clinical data is one of the most important requirements of the EU-MDR. Manufacturers should take care to collect adequate and valid clinical data.

c. Education and Information

Medical device manufacturers should continuously educate and inform their staff about regulatory changes. This is necessary to manage compliance processes.

d. Good Communication with Notified Bodies

Open and continuous communication with notified bodies facilitates the compliance process. Producers must submit all required documentation for audit processes in a timely manner.

Summary of Important Dates for Manufacturers

1. May 2017 , the MDR was published with an initial effective date of May 2020.

2. May 2020 , the effective date of the MDR is postponed by 1 year due to the Covid pandemic.

May 2021, the MDR becomes applicable and enforceable. All new devices or devices with expired certification must now be MDR compliant.

4. December 2027, all Class IIB and Class III device certificates issued under previous directives that have not yet expired will expire.

5. December 2028, all Class I and Class IIA device certificates issued under previous directives that have not yet expired will no longer be valid. All medical devices marketed in the EU must now carry the MDR CE certificate.

Nanolab Laboratories Group continues to provide services within the scope of Medical Device Analysis.

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