Medical Devices

A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.

There are more than 500,000 different types of medical devices available, covering anything from wheelchairs and glasses to pacemakers, mobile phone apps and state-of-the-art surgical equipment.

Devices are classified by intended purpose and inherent risk device. The regulatory requirements for each risk class are different over the course of the products lifecycle. In Europe, a certificate of conformance (CE mark) is required to registered the device prior to the market access. Class I medical devices have the lowest perceived risk and the manufacturer can self-certify the conformance of the device against the European standards. Higher risk class devices must undergo scrutiny from a Notified Body (NB) before the device can be granted a certificate of conformity and be placed on the market.

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Notified Bodies and CE Marking

Notified Bodies (NBs) are designated by competent authorities to ensure that medical devices manufacturers meet stringent safety requirements. This includes the review of safety documentation, technical documentation and quality control processes. A medical device manufacturer has the option to submit to any notified body of their choosing.

Once the safety requirements have been met, a declaration of conformity will be granted and signed by the manufacturer. This document may be required to be submitted to the Heath Authority when submitting the MAA for the drug device combination product.

At this point, the device and its packaging can be CE marked which symbolises the product meets EU legislation.

European Database on Medical Devices (EUDAMED)

EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies.

In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU.

EUDAMED will be composed of six modules related to:

1.Actor Registration

2.Unique device identification (UDI) and Device registration

3.Notified bodies and certificates

4.Clinical investigations

5.Performance studies

6.Vigilance and market surveillance

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Types of Medical Devices

Type of Medical Device	Description	Examples
Co-packaged	The medical device and medicinal product are separate items packed together in the same secondary packaging.	•Spoon •Measuring Cup •Additional Safety Needles •Vial Adapters •Syringes for oral administration •Refillable pens and injectors using cartridges •Nebulisers, vaporisers, pumps for medicinal product delivery •Electronic tablet dispensers.
Combined advanced therapy medicinal products (ATMPs)	Combined ATMPs can be gene, cell, or tissue based, but they also contain one or more medical devices as an integral part of the medicine. An example of a Combined ATMP is cells embedded in a scaffold, which is often used in tissue engineering.	•Cells embedded into a scaffold
Companion diagnostic	A companion diagnostic is a medical device, often an in vitro diagnostic (IVD), which provides information that is essential for the safe and effective use of a corresponding drug or biological product.	•Blood Glucose Monitoring Devices •Drugs of Abuse Tests •Home Use Tests
Integral – Administration device	The medical device and medicinal product form one single integrated product. Here, the device is intended to administer a medicinal product, and the two constituent parts form a single, non-reusable integral product.
Integral – Not administration device	The medical device and medicinal product form one single integrated product. Here, the device is not intended to administer a medicinal product, whilst the two constituent parts form a single, non-reusable integral product.	•Nozzle on top of a container •Syringe for reconstitution (without purpose for administration of the medicinal product)
Referenced in the product information of the medicinal product	The medical device is compatible with the medicinal product, whilst not directly being packaged/sold with the medicinal product.	“Auto-injector device is available should patients want to make their injection with an injection device. The autoinjector should be used as recommended in the information provided by the device manufacturer”