New MDCG Guidance on classification of medical devices under MDR

The MDCG has published a very important Guidance on classification of medical devices under the MDR – Regulation (EU) 2017/745: MDCG 2021-24. The document mainly analyzes the classification rules of Annex VIII of the MDR and most importantly provides examples for each Rule and the applicable classes. Moreover, it includes some useful definitions of for ex.  Substance, Integrated or incorporated diagnostic functionEssential impact, etc. It should be noted though that the guidance does not constitute a legally binding document, nevertheless, it can provide useful guidance to manufacturers when classifying their devices.

Below, we provide few examples taken from the MDCG 2021-24.

Concerning the non-invasive devices:  

Rule 1:  Devices that either are not come in direct contact with the patient or are in contact with intact skin  

  • Class I: non-invasive conductive gel (e.g. ultrasound gel)  


Rule 2:  Devices for channeling or storing for eventual administration,  

  • Class IIa : Devices intended for temporary storage and transport of organs for transplantation (e.g. containers, bags) 
  • Class IIb: blood bags  
  • Class I : Devices intended for use with a temporary containment or storage function as cups and spoons intended for administering medicines 


Rule 3: Devices that modify biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body 

  • Class IIb: Devices intended to separate cells by physical means, e.g. gradient medium for sperm separation  
  • Class IIa: Removal of carbon dioxide from the blood and/or adding oxygen  
  • Class III: Substances or mixture of substances for transport, perfusion, storage of organs intended for transplantation that do not achieve the principal intended action by pharmacological, immunological or metabolic means  


Rule 4: Devices in contact with injured skin or mucous membrane  

  • Class I: Ostomy bags  
  • Class IIb: Dressings for severe decubitus wounds  

Concerning the invasive devices:  

Rule 5: Devices Invasive to body orifices  

  • Class I: Examination Gloves  
  • Class IIa: Nasobilliary Tubes  
  • Class IIb: Urethral Stents  


Rule 6: Surgically invasive devices intended for transient use  

  • Class I: Drill Bits  
  • Class IIa: Needles  
  • Class III: Cardiovascular Catheters  


Rule 7Surgically invasive devices intended for short-term use 

  • Class IIa: Skin closure devices  
  • Class IIb: Vascular closure devices  
  • Class III: Cardiovascular catheters  


Rule 8Implantable devices and long-term surgically invasive devices  

  • Class IIb: Tissue augmentation implants (except breasts) 
  • Class III: Prosthetic heart valves  


Rule 9: Active therapeutic devices intended to administer or exchange energy, as well as active devices intended to control/monitor/directly influence certain devices  

  • Class IIa Example in Ultrasound: equipment for physiotherapy  
  • Class IIb Example in Kinetic Energy: lung ventilators  
  • Class III: Programming units and pacing system analyzers  


Rule 10: Active devices for diagnosis and monitoring or intended for diagnostic or therapeutic radiology  

  • Class I: examination lamps  
  • Class IIa: electrocardiographs  
  • Class IIb: Diagnostic X-ray machine  


Rule 11Software intended to provide information to inform decisions with diagnosis or therapeutic purposes or software intended to monitor physiological processes  

  • Class IIa: MDSW intended to rank therapeutic suggestions for a health care professional based on patient history, imaging test results and patient characteristics as MSDW that lists and ranks all available chemotherapy options for BRCA-positive individuals  
  • Class IIb: A mobile app intended to analyze a user’s heartbeat, detect abnormalities and and inform a physician accordingly  
  • Class III: MDSW intended to perform diagnosis by means of image analysis for making treatment decisions in patients with acute stroke  
  • Class I: MDSW app intended to support conception by calculating the user’s fertility status based on a validated statistical algorithm  

Class 12: Active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body  

  • Class IIa: suction pump 
  • Class IIb: Anaesthesia machines  


Rule 13All other active devices  

  • Class I: Electric wheelchairs 


Rule 14: Devices incorporating, as an integral part, an ancillary medicinal product, and medicinal products derived from human blood or blood plasma  

  • Class III: Bone cement with antibiotics  


Rule 15: Devices used for contraception or prevention of sexually transmitted diseases  

  • Class IIb: condoms  
  • Class III: Tubal ligation devices  


Rule 16: Specifically disinfecting, cleaning, rinsing, hydrating or sterilizing devices (contact lenses) 

  • Class IIb: Cleaners for contact lenses  
  • Class IIa: Disinfecting solutions specifically intended for non-invasive medical devices  


Rule 17: Devices to record X-ray diagnostic images  

  • Class IIa: X-ray films  


Rule 18: Devices manufactured utilizing tissue or cells of human and animal origin or their derivatives  

  • Class III: Animal derived biological heart valves  


Rule 19: Devices incorporating or consisting of nanomaterial  

  • Class III: Bone fillers with nanomaterials in their formulation  
  • Class IIb: Bone fixation screws/plates with a strongly bound nano-coating high potential  
  • Class IIa: Dental filling materials  


Rule 20: Invasive Devices, intended to administer medicinal product by inhalation  

  • Class IIa: Inhalers for nicotine replacement therapy (no nicotine included) 
  • Class IIb: Spacer intended for metered dose inhalers attached to the inhaler  


Rule 21: Devices composed of substances that are introduced via a body orifice or applied to the skin  

  • Class III: Na/Mg alginate, xyloglucan 
  • Class IIa: salt water used e.g. as nose or throat sprays  
  • Class IIb: Eye drops for hydration  


You can see the complete MDCG Guidance on this link – in our MDCG Library. 

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