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Navigating Regulatory Gray Areas: Borderline Devices in the EU MDR and IVDR Era


Navigating Regulatory Gray Areas: Borderline Devices in the EU MDR and IVDR Era

In the world of medical devices, categorization and classification are essential processes that determine how products are regulated and brought to market. However, some devices don't neatly fit into a single category, leading to the concept of "borderline devices." The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) address this issue. In this blog post, we will explore what borderline devices are and how they are managed under these regulations.


Understanding Borderline Devices

Borderline devices, as the name suggests, are medical devices that fall on the borderline between different categories or between medical devices and other product types, such as medicinal Products, cosmetics or food supplements. These devices pose a unique challenge in terms of regulatory classification and compliance, as they may exhibit characteristics of both medical devices and non-medical products. The borderline products could be –


  • Borderline between Medical Devices and IVDs (Regulation (EU) 2017/746)

  • Borderline between Medical Devices and Medicinal Products, including Advanced Therapy Medicinal Products (ATMPs) (Directive 2001/83/EC)

  • Borderline between Medical Devices and Biocides (Regulation (EU) No 528/2012)

  • Borderline between Medical Devices and Cosmetic Products (Regulation (EU) No 1223/2009)

  • Borderline between Medical Devices and Food (Regulation (EC) 178/2002)

  • Borderline between Medical Devices and Personal Protective Equipment (Regulation (EU) 2016/425)

  • Borderline between Medical Devices and substances of human Origin (Directive 2004/23/EC or Directive 2002/98/EC)

  • Borderline between Medical Devices and general consumer products (Directive 2001/95/EC)

  • Other Medical Device borderlines


The Helsinki Procedure for Borderline Devices

The Helsinki Procedure for Borderline Devices is a specific process designed to provide guidance and decisions on the classification of borderline medical devices within the European Union (EU) regulatory framework. It is not explicitly mentioned in Regulation (EU) 2017/745 on medical devices (MDR) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Instead, it is a practice that involves cooperation and consultation among EU Member States and the European Commission.


If you are dealing with a borderline device and are uncertain about its classification, it is advisable to engage with your National Competent Authority and, if necessary, initiate the Helsinki Procedure to seek a definitive decision from the European Commission.


The EU MDR and EU IVDR both recognize the existence of borderline devices and provide guidelines for their classification and regulation to ensure patient safety and product quality. The Medical Device Coordination Group (MDCG) from time-to-time releases “Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices” as a support tool listing all the recognized borderline products and the agreement reached by Member states under the Helsinki Procedure.


Recognized Borderline Medical Devices and their Qualification

So far, the borderline medical devices with ATMPs, Biocides, PPEs have been qualified under the Helsinki Procedures.

Conflicting Product Class

Product

Qualification

Regulations

ATMPs


Nasal spray with antibodies for COVID-19


Not a Medical Device


Directive 2001/83/EC

Graphite Crucible

Not a Medical Device

Directive 2001/83/EC

Product for professional removal of dental biofilm

Single Integral Combination Product

-Pre-Filled subjected to Regulation (EU) 2017/745 (Class III) -Medicinal Product Directive 2001/83/EC.

​Root canal irrigation solution containing sodium hypochlorite (NaOCl) or chlorhexidine digluconate (CHX)

Medical Device (Class III)

(provided manufacturer presents evidence that NaOCl and CHX doesnot exhibit antibacterial or antiseptic action

Regulation (EU) 2017/745

Biocides

Substance for textile treatment

Biocide

Regulation (EU) No 528/2012

Personal Protective Equipment

​Rescue bag for patient transport

Medical Device (Class I)

Regulation (EU) 2017/745

Plexiglas box for caregiver protection

Personal Protective Equipment

​Regulation (EU) 2016/425

Others

Smartphone application for STI prevention strategies

Not a Medical Device

Medical Calculators

Medical Device (Atleast Class IIa)

Regulation (EU) 2017/745

​Needle Counters

Not a Medical Device

Temperature sensors embedded in orthopaedic devices for compliance tracking

Not a Medical Device

System intended to produce sclerosing foam

Stand-alone product is Not a Medical Device. If marketed as procedure pack along with CE marked Syringe, the whole kit is subjected to EU MDR

Challenges and Considerations


Navigating the regulatory landscape for borderline devices under the EU MDR and IVDR can be complex. Here are some key considerations:


  1. Expert Consultation: Manufacturers of borderline devices should consider seeking expert advice early in the development process to determine the correct classification and regulatory pathway.

  2. Documentation: Thorough documentation of the device's characteristics, intended use, and risk profile is essential for the classification process.

  3. Continuous Monitoring: Borderline devices may require ongoing monitoring and adaptation to changing regulations or guidance documents.

  4. Post-Market Surveillance: Manufacturers must establish robust post-market surveillance systems to monitor the performance and safety of borderline devices once they are on the market.


Borderline devices are a unique challenge in the world of medical devices, but the EU MDR and IVDR provide clearer guidelines for their classification and regulation. Manufacturers of such devices must navigate these regulations carefully, consulting experts and ensuring compliance to bring safe and effective products to market while prioritizing patient safety.


As the medical device industry evolves, ongoing communication with regulatory authorities and a commitment to staying informed about the latest guidance are crucial for successfully managing borderline devices under the EU MDR and IVDR.


Are you ready to embark on your regulatory journey with borderline devices under EU MDR and IVDR?


Stay informed, ensure compliance, and prioritize patient safety. Dive deeper into the intricacies of regulatory compliance with the right Regulatory Partner like Artixio. Your success in the world of medical devices begins here.





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