There is a diverse range of products that fall under Class B by definition. Accordingly, this includes devices not covered by other classification rules. It also includes clinical chemistry tests and some self testing IVDs like urine dipstick tests for bacteria in urine, cholesterol tests, and many more.
Manufacturers of Class B devices have only one option, and they must apply for the Annex IX route.
- They must comply with Annex IX Chapter I requirements for QMS, which will be certified by the notified body.
- They must also comply with Annex IX Chapter II requirements for technical documentation. The notified body will review the technical documentation of one representative device for each category of devices, and the category of the device is based on the IVR codes.
- For Class B self tests or near patient tests, there are some additional requirements in Annex IX, Section 5.1, and all of these devices will be audited. In this case, a product specific certificate will be issued by the notified body.
The definition for this class of devices includes products for testing transfusion or transplantation compatibility. It also includes all infectious agents tests, cancer testing, genetic testing, companion diagnostics, prenatal testing, cancer screening tests and many others. The level of scrutiny by the notified bodies is far more intensified for Class C devices.
Manufacturers have two options:
- Annex IX route,in which they must comply with:
- Annex IX Chapter I – QMS
- Annex IX Chapter II Section 4 – Assessment of technical documentation for at least one representative device of each generic group
- Annex X + Annex XI route (combination) in which:
- Annex X is a Type Examination (technical documentation review as well as physical or laboratory tests on a representative sample of generic device groups)
- Annex XI Production Quality Assurance (which involves a quality systems audit of the production of the selected device)
- For Class C self tests and near patient tests, no sampling of devices will be done by the notified bodies, meaning all devices will be audited. Thus, the manufacturers must comply with the requirements in Annex IX Section 5.1.
- For Class C Companion diagnostics, every device will be audited and the notified body will consult with the EMA or any other competent authority designated by Member States. The manufacturers must also comply with requirements in Annex IX Section 5.2.
Both Article 2 of the IVDR and the MDCG guidelines define what is meant by generic devices, and it is as follows:
“generic device group means a set of devices having the same or similar intended purposes, or a commonality of technology allowing them to be classified in a generic manner.”
In the final definition available is the highest risk class, and these devices include tests for highly transmissible and life threatening agents like HIV, HBV, HCV or syphilis, blood grouping reagents and kits, and others. The level of scrutiny by the notified bodies is far more intensified for Class D devices.
Manufacturers have two options here:
- Annex IX route for which they must comply with:
- Annex IX Chapter I – QMS
- Annex IX Chapter II Section 4 – Assessment of technical documentation for each device
- Annex X + Annex XI combination route in which:
- Annex X is Type examination (technical documentation review, as well as physical or laboratory tests on the devices)
- Annex XI Production Quality Assurance (which involves a quality systems audit of the production of the devices)
There are some additional requirements for Class D devices that are implemented irrespective of the option chosen. As part of their conformity assessment, Class D devices will also undergo EU reference laboratory testing, where the EU reference labs will test for all the performance claims made by the manufacturer to a CS (common specifications), harmonized standard, or any other standard provided by the manufacturer. If no common specifications are available, an expert panel will be consulted. Further, Class D devices will be subject to batch verifications of each batch that is manufactured, meaning the notified bodies will review QC data and documentation before each batch can be released.
The first step towards successful CE marking is defining the intended purpose and determining the correct risk class of the device as per Annex VIII. This will help the manufacturer identify the appropriate conformity assessment procedure required for obtaining the CE mark, which is the next step towards launching products in the European markets.