New MDCG Guidance on classification of medical devices under MDR · MDlaw – Information platform on European medical device regulations

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 function, Essential 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 7: Surgically invasive devices intended for short-term use

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

Rule 8: Implantable 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 11: Software 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 13: All 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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