Medical Device Classification in the EU MDR
One of the first considerations for medical device manufacturers who are seeking to place their products in the European market is to determine which is the appropriate classification for their devices. The classification of the device will impact on how and when you will engage with your Notified Body.
As the market transitions from the Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Device (AIMDD) (90/385/EEC) to the Medical Device Regulation (MDR) No. 2017/745, device manufacturers must note the changes in requirements for device classification. For example, devices that had previously been included in the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC are now covered in the Medical Device Regulation (MDR). It is also important to note the MDR also includes products in Annex XVI, that do not have a medical purpose, also must meet MDR requirements, despite having an aesthetic or a non-medical purpose.
Like the FDA, the EU requirements also employ a device risk classification scheme, however, they classification process varies between the two Regions. In the MDD the rules can be found in Annex IX and in the MDR the rules are expanded and can be found in Annex VIII.
Both the MDD and the MDR group medical devices according to four basic categories:
- Non-invasive devices
- Invasive medical devices
- Active medical devices
- Special Rules
Devices are segmented into the classes noted below.:
- Class I – Provided non-sterile or do not have a measuring function (low risk)
- Class Is: A class I product that is delivered sterile
- Class Im: A product with a measuring function
- Class Ir: New sub-class for products that are reprocessed or re-used
- Class IIa (medium risk)
- Class IIb (medium/high risk)
- Class III (high risk)
Device Classification rules
The MDD contained 18 rules for classification. Those rules can be found in Annex IX of the MDD. With the MDR, the rules are expanded. There are now 22 rules in Annex VIII of the MDR. In both cases the rules are based on the potential risks associated with the device, technical design and manufacture of the device.
- Rule 1– Non-invasive devices
- Rule 2 – Non-invasive devices intended for channeling or storing (Which includes cells)
- Rule 3 – Non-invasive devices that modify biological or chemical composition of blood, body liquids, other liquids and cells
- Rule 4 – Non-invasive devices in contact with injured skin or mucous membrane
- Rule 5 – Devices invasive in body orifices
- Rule 6 – Surgically invasive devices for transient use
- Rule 7 – Surgically invasive devices for short term use
- Rule 8 – Surgically invasive devices for long term use and implantable (including any device administering medicinal products, surgical mesh or spinal disc)
- Rule 9 – Active therapeutic devices intended to exchange or administer energy
- Rule 10 – Active devices for diagnosis & monitoring, emit ionizing radiation
- Rule 11 – Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes (from class I to class III)
- Rule 12 – Active devices intended to administer and/or remove medicinal products, body liquids or other substances
- Rule 13 – All other active devices
- Rule 14 – Devices incorporating a medicinal substance including human blood or plasma
- Rule 15 – Contraception or prevention of the transmission of sexually transmitted diseases
- Rule 16 – Specific disinfecting, cleaning and rinsing devices
- Rule 17 – Devices specifically intended for recording of diagnostic images generated by X-ray radiation
- Rule 18 – Devices utilizing non-viable tissues or cells of human origin or tissues of animal or derivatives
Four new rules included in the MDR:
- Rule 19 – Devices incorporating or consisting of nanomaterial
- Rule 20 – Invasive devices with respect to body orifices to administer medicinal products by inhalation
- Rule 21 – Substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed
- Rule 22 – Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management
As can be expected, the greater the risk presented by the device, and the higher the classification, the greater is the required Notified Body involvement. In order to avoid costly changes and significant time-to-market delays for your product, it is best to discuss classification with your Notified Body as early as possible in the process.
To discuss classification or any aspect of CE Marking for your medical device with ECM’s team of experts, call us at (833) 326-2378, or to use our contact form click here.