MDR Analysis: Does your medical device fall under the scope of new European regulations?

By Stewart Eisenhart and Ronald Boumans, Emergo Group

The draft MDR text (see page 32 for the definition) as well as its accompanying Annex XV (page 352) lay out clear indications as to which types of devices will have to comply with the new requirements and which will be covered by separate regulations. Before we go into detail, you might want to read last week’s high level overview of the MDR changes, or download our whitepaper on the MDR.

It is important to note that the MDR covers devices that previously fell under two separate European directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD); in vitro diagnostic devices will be covered by the new In Vitro Diagnostics Directive (IVDR).

How the MDR defines “medical device”

The MDR defines the term “medical device” as any “instrument, apparatus, appliance, software, implant, reagent, material or other article” intended to be used for any of the following medical purposes:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability or injury, where prevention of disability and injury is excluded
• Investigation, replacement or modification of an anatomical, physiological or pathological process
• Providing data via in vitro examination of samples derived from a human body

The new regulation also specifies particular types of products that also qualify as medical devices requiring CE Marking:

• Products intended for cleaning, disinfection and sterilization of medical devices
• Devices for the control and support of conception, even if they achieve their intended purpose by pharmacological, immunological or metabolic means.

Of course, manufacturers currently certified to market their devices in the European Union should familiarize themselves with the MDR text to determine whether their products do indeed fall under the scope of the new regulation, but some examples of products that do and do not fall under the MDR are provided below.

Is my product a device according to the MDR?

Yes	No
Products used for cleaning, disinfecting or sterilizing other medical devices (e.g. scope disinfector)	Products that utilize viable biological components for their intended purpose (e.g. lactobacillus)
Devices for purposes of control or support of conception (e.g. condom, intrauterine device)	IVDs, medicinal products, cosmetics and food products; these are regulated elsewhere
Software used for any purpose covered by MDR’s definition of a medical device	Software used for general administrative purposes, even in healthcare settings

Annex XV devices

In addition to products meeting the MDR’s definition of medical devices, Annex XV of the new regulation lists groups of products that, despite having no intended medical purpose, must also meet MDR requirements.

The major product groups in Annex XV include:

• Contact lenses and other products used in or on the eye
• Products introduced into the body via surgically invasive means in order to modify anatomy
• Products and substances used for facial or other subcutaneous filling
• Equipment used for liposuction, lipolysis or lipoplasty
• High-intensity electromagnetic radiation equipment used for skin treatments such as tattoo and hair removal
• Equipment using electrical or magnetic currents to stimulate the brain

Accessories

Accessories are products that are intended to enable a device to be used in accordance with its intended purpose or to assist the medical functionality of the medical device. They are covered in the scope of the Regulation, similar to the requirements in the Directives. As some products are now added to the definition of a medical device, their accessories will also be covered by the scope of the Regulation. Therefore it is necessary to verify all products used together with these new categories of medical devices to identify accessories as defined in the MDR.

Some examples:

• Nets for sterilization;
• Devices used to position or remove invasive or implantable contraceptives;
• Software used for creating images of the expected effects of breast implants

Borderline products

For the majority of the products it will be relatively straightforward to determine their status. However, Emergo expects that this Regulation will soon create its own list of borderline products. Emergo is interested in the devices and accessories that you consider medical devices, or that should not be covered by this scope. So please send us your examples, with a clear description of the intended purpose and mode of action, so we can analyze the consequences of the new definition.

Gray areas

In some instances, determining whether a product qualifies as a medical device under the MDR will not be a cut and dry affair. As manufacturers begin compliance efforts under the new regulations, some product types will elicit questions from manufacturers that will require further clarification from Brussels.

One such question likely to arise pertains to products listed in Annex XV and accessories. By definition, accessories must be used in relation to the medical purpose of a device, but the products in Annex XV have no medical purpose. So, does this mean that no accessories exist for Annex XV devices?

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

Ronald Boumans is a Senior Regulatory Consultant at Emergo‘s office in The Hague. 

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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