Manual on Borderline and Classification Under the IVDR and MDR

The Borderline and Classification Working Group (BCWG) has released Version 4 (September 2025) of the Manual on Borderline and Classification for Medical Devices and IVDs. This update clarifies a number of new borderline cases and provides additional classification guidance under the MDR (EU) 2017/745 and IVDR (EU) 2017/746. 

Compared to Version 3 (September 2023), the key updates were introduced.

Key Updates

Key updates on the new manual on Borderline and Classification under the MDR and IVDR include:

• Red blood cell additive solutions containing adenine: Medical devices; adenine has ancillary action to device as medicinal substance. 

• Dual action cream (menthol & capsaicin): Not a medical device; action is pharmacological. 

• Lactose vaginal tablets: Not a medical device; effect is metabolic. 

• Microabrasion dental stain removers: Not medical devices; removal of dental stains to improve the appearance of teeth does not represent a medical purpose. May fall under Regulation (EC) No 1223/2009 on cosmetic products. 

• Medical examination table covers: Confirmed as medical devices (disease prevention). 

• Mobile sterile air systems: Not medical devices (environmental control). 

Stricter Qualification Boundaries 

Several products are now explicitly excluded from MDR scope, including: 

• Dual-action creams (menthol & capsaicin) 

• Lactose vaginal tablets 

• Microabrasion dental stain removers 

• Mobile sterile air systems 

Next Steps for Industry 

Manufacturers should: 

• Review product portfolios to determine whether any products are excluded from MDR scope. 

• Identify and evaluate the appropriate alternative regulatory frameworks (e.g., Cosmetics Regulation, Pharmaceutical Directive, General Product Safety Regulation). 

• Update labeling, claims, and supporting documentation to ensure alignment with the applicable framework. 

How MedEnvoy Can Support

MedEnvoy helps manufacturers navigate scope changes by conducting portfolio impact assessments, advising on the correct regulatory pathways, and preparing documentation updates, this includes Borderline Classification under the IVDR and MDR. Our expertise across multiple frameworks ensures smooth transitions and continued market access. We encourage you to contact our team for tailored support.