Medical devices - Class IIb
A Class IIb device is, or may be in the future, subject to special controls that ensure the safety and efficacy of the device. Devices in class II are held to a higher level of assurance that they will perform as indicated and will not cause injury or harm to patient or user. They may be subject to clinical trials and 510(k) submission prior to release for general use. Devices in this class are typically non-invasive and include x-ray machines, PACS, and other modalities.
CE marking of Class IIb devices meets the 93/42 EEC Medical Device Directives, Annexes VII and I. To this end, the following requirements should be met:
- Technical File for each family of devices should be prepared. This file should contain legal information, documentation, manufacturing process and performance of the product to show its effectiveness and safety. It includes the product Risk Analysis according to the EN 14971 harmonized European Standard, material safety data sheets, biocompatibility of materials, hygiene and sterility tests, manufacturing processes control procedures, operation manual/instructions, and any relevant documentation, as required by Exhibit I “Essential Requirements” of MDD, including clinical and medical support information. According to the type of device, some of these requirements may not apply.
- The Manufacturer must implement a Medical Quality Management System that will comply with the requirements of the MDD 93/42/EEC directive. The best, it to adopt a harmonized standard such as ISO 13485:2003 which s now the gold QMS standard in this Industry. In addition, we recommend, for commercial reasons, that this system should meet ISO 9001:2000, but ISO 9001:2000 alone does not comply with the requirements of the medical equipment directives. For more information, see CE QMS Requirements.
- Choose Conformity Assessment Route: refer the flow chart below.
- Declaration of Conformity.
- Ensure the device is a Class IIb medical device.
- Vigilance and Post Market Surveillance. (affix CE marking & market the products)
- Appoint an Authorized Representative. (register with the Competent Authority)
The conformity assessment routes for Class IIb Medical Devices
In the case of devices falling within Class IIb, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:
(iii) The procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).
There are two routes:
- Notified Body must carry out either an Annex II audit of the full quality assurance system (ISO 13485:2003),
2. Type-examination (Annex III) plus one of the three options given here:
- Examination and testing of each product or homogenous batch of products (Annex IV); or
- Audit of the production quality assurance system (Annex V :) ISO 13485:2003 (excluding Design) or
- Audit of final inspection and testing (Annex VI :) ISO 13485:2003 (excluding Design & Manufacture)
Once the manufacturer has received certification from the Notified Body he may CE mark his products and place them on the market.