New MDCG guidance shows how devices fit into MDR’s classification rules

Regulatory NewsRegulatory News | 06 October 2021 |  By 

The European Commission’s Medical Devices Coordinating Group (MDCG) on Monday issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are placed on the EU market.
Under the MDR, which went into effect on 26 May 2021, devices are divided into four classes: I, IIa, IIb and III. Devices are ranked according to risk from class I for the lowest-risk devices to class III for the highest.  Annex VIII of the MDR further categorizes devices as non-invasive, invasive oractive, or falling into another “specials rules” category for contraceptives, contact lens solutions and device sterilizers.
The guidance provides a high-level overview of the regulations and graphical summaries to explain medical device classifications, showing how the 22 rules in Chapter 3 of the MDR that govern categorization of medical devices intersect with the four risk classes of medical devices, and with each other.
For example, the graphic illustration of the classification of Rule 5 non-surgical devices — those that are invasive in a bodily orifice or a stoma — notes other rules that might need to be taken into consideration. Rule 20 governs such devices that administer medicinal products by inhalation, so the guidance illustrates that this rule might better apply to a device such as an inhaler that might otherwise fall under Rule 5.
The guidance also graphically depicts how some exemplar devices’ risk classifications are determined, according to their duration of use or other intended uses.
The MDCG guidance also offers extensive examples of the specific devices that fall into the four groups and into each of the 22 rules.
As an example of the level of detail presented in the guidance, MDCG goes on to list about two dozen Rule 1 category devices, including hospital beds, wheelchairs, and body liquid collection devices such as urine collection bottles and incontinence pads. Other examples provided include devices used to immobilize body parts or apply force or compression, such as non-sterile dressings, plaster of Paris, cervical collars and gravity traction devices, stethoscopes, incision drapes and non-invasive gels.
Other rules govern more invasive devices, and MDCG provides for a range of risk classifications for these types of devices. For example, Rule 6 covers surgically invasive devices meant to be used for less than an hour. These devices generally fall into class IIa, although some devices related to cardiovascular or central nervous system monitoring or surgery are class III. Reusable surgical instruments are classified as class I.
What to do in conflicts
The guidance acknowledges that although existing rules cover the “vast majority of existing devices,” a “small number of devices may be more difficult to classify.”
Where disputes arise between the manufacturer and the notified body on the device’s classification, these cases should be referred to the competent authority of the Member State in which the manufacturer has its registered place of business. The competent authority will then render a decision on the device’s classification.
Separately, competent authorities may also ask the MDCG Borderline and Classification Working Group to discuss and review devices whose classifications are particularly complex. When the working group agrees on a classification of such a device, the group’s position is published in MDCG’s borderline and classification manual for reference.
The guidance is aligned with the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document issued by the Global Harmonization Task Force SG1/N77:2012.
MDCG guidance on medical device classifications


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Tags: EU, MDR, regulations

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