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New EU Borderline guidance

A Comprehensive Manual on Borderline Classification for Medical Devices under EU Regulations


In the ever-evolving field of medical devices, ensuring compliance with regulations is paramount to ensure the safety and efficacy of these products. In the European Union (EU), medical devices are governed by strict regulations, with Regulation (EU) 2017/745 for medical devices and Regulation (EU) 2017/746 for in vitro diagnostic medical devices being the cornerstones of this framework. To aid manufacturers, authorities, and other stakeholders, the European Commission periodically updates the guidance documents related to these regulations. In September 2023, Version 3 of the "Manual on Borderline and Classification for Medical Devices" was released, offering crucial insights into the classification and borderline determinations.

Understanding Borderline Classification

Borderline classification refers to the process of determining whether a product falls within the scope of medical devices, in vitro diagnostic medical devices, or other regulatory categories like drugs or cosmetics. This determination is vital because it dictates the applicable regulations and conformity assessment procedures. The Manual serves as a vital resource for making these complex decisions.

Key Changes in Version 3

Version 3 of the Manual brings several important updates and changes to streamline the classification process and enhance clarity:

1. Expanded Scope

The manual has been expanded to encompass the latest developments in medical technology, addressing innovative products that may not have been previously considered. This broader scope reflects the dynamic nature of the medical device industry.

2. Comprehensive Decision Flowcharts

One of the notable improvements is the inclusion of comprehensive decision flowcharts. These flowcharts guide users through a series of questions, helping them navigate the classification process systematically. This feature aids in ensuring consistency and accuracy in decision-making.

3. Inclusion of Case Studies

To illustrate complex scenarios, the manual now includes practical case studies. These real-world examples shed light on how to apply the guidance in specific situations, making it easier for stakeholders to understand and implement the regulations.

4. Clarity on Accessory Classification

Version 3 also provides greater clarity on the classification of accessories. The new guidance addresses scenarios where an accessory may change its classification based on its intended use in combination with different parent devices.

5. Alignment with International Standards

The manual aligns more closely with international standards, fostering harmonization and simplifying global market access for medical device manufacturers.

Benefits of Using the Manual

Using the Manual on Borderline and Classification for Medical Devices offers several benefits for stakeholders:

1. Regulatory Compliance

By following the guidance in the manual, manufacturers can ensure that their products are correctly classified and meet the regulatory requirements of the EU. This helps in avoiding costly compliance issues and regulatory hurdles.

2. Consistency

The comprehensive decision flowcharts and case studies promote consistency in decision-making, reducing the risk of misclassification and associated legal consequences.

3. Transparency

The manual provides a transparent and structured approach to classification, helping manufacturers and regulators understand the thought process behind each decision.

4. Facilitates Innovation

With a broader scope and clear guidelines, the manual encourages innovation by allowing manufacturers to confidently explore new technologies and applications while staying within regulatory boundaries.

Find the new guidance here:

Download PDF • 289KB


The release of Version 3 of the Manual on Borderline and Classification for Medical Devices under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 is a significant milestone in the world of medical device regulation. It equips stakeholders with the knowledge and tools needed to navigate the complex landscape of classification and ensures that medical devices entering the EU market comply with the highest safety and performance standards.

Manufacturers, regulatory authorities, and other interested parties are encouraged to utilize this comprehensive resource to foster compliance, consistency, and innovation in the ever-evolving field of medical devices within the EU. With Version 3, the EU continues to demonstrate its commitment to safeguarding public health and promoting technological advancements in healthcare.

For those seeking expert guidance and assistance in handling borderline products, AF Pharma stands ready to provide invaluable support. AF Pharma's experienced team is well-versed in the intricacies of EU medical device regulations and can assist you in navigating the classification process, ensuring that your products meet all compliance requirements. With AF Pharma as your partner, you can confidently bring your medical devices to the EU market, knowing that you have a trusted ally in regulatory compliance.

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