If you are a medical device manufacturer who wants to legally CE your products in Europe, then you must ensure you comply with the appropriate medical device directive or regulation as set out by the EU Commission.
Understanding the EU MDR classification system
In Europe, there is a rule-based classification scheme for medical devices. Medical devices are therefore classified under:
- The Medical Device Regulation (MDR) No. 2017/745 for medical devices, this regulation also includes products mentioned in Annex XCI that do not have a medical purpose
- Active implantable medical devices
- In Vitro Diagnostic Device Regulation (IVDR) No. 2017/746 for IVD devices
The MDR regulations are complicated; for example, Annex VIII of the MDR has 22 rules associated with it. And the requirements for compliance with the MDR and level of regulatory control increase with the perceived risk level associated with the end product (medical device).
The first stage in determining what classification your medical device is in Europe is to determine whether your medical device is:
- Non-invasive: the device does not penetrate the body through any orifice or surface
- Invasive: the device penetrates the body wholly or partially through any orifice or surface
- Active medical devices: to work, the device relies on a source of energy not generated by the human body
There are also special rules for contraceptive, disinfectant and radiological diagnostic medical devices.
Within this, devices are then further separated into the following classes:
- Class I – A medical device with low risk
- Class IIa – A medical device with low to medium risk
- Class IIb – A medical device with medium to high risk
- Class III – A medical device with the highest possible risk
Under the EU MDR, Class I medical devices have the lowest perceived risk, so they can often be self-certified by the manufacturer. Medical devices that fall under this category include bandages, glasses and stethoscopes.
However, within Class I, some further sub-classifications cover those medical devices that are perceived to have a higher risk, so a notified body must be involved before CE marking is affixed. These sub-categories are:
- Class Is: medical device must be presented sterile
- Class Im: medical device has a measuring feature
- Class Ir: medical device is a reusable surgical instrument
Class IIa and IIb devices need a declaration of conformity from a notified body following conformity assessment as they are classed as medium and medium to high risk.
Class III medical devices are devices that are considered to be high-risk, and so they are subject to the most stringent requirements, including clinical evaluation.
Key tasks for complying with EU MDR device classification
Several studies need to be undertaken before a new EU Declaration of Conformity (DoC) to the MDR is drawn up, and the device is placed on the market, including:
- Putting a Quality Management System (ISO 13485) into place that is certified by an accreditation or notified body.
- Assessing the device conformity in Technical Documentation to comply with the General Safety and Performance Requirements (GSPRs).
- Preparation of all the required information to accompany the device, such as ensuring the IFU and labels are revised to reflect all the newly requested changes.
- Designation of a Person Responsible for Regulatory Compliance meeting the requirements of Article 15 qualification.
In summary, rule 11 of the EU MDR defines, classifies and establishes the requirements for medical devices and their classification. If you are unsure how to classify your medical device, please contact us – we are ready to help.