Medical devices - Class III: General Controls and Premarket Approval

A Class III device needs to go through premarket approval (PMA) by the FDA before it can be marketed for use. Class III devices are usually invasive, life-sustaining, life-supporting, or is used “in preventing impairment of human health or if the device presents a potential unreasonable risk of illness or injury”.

In order to CE mark Class III devices the following requirements should be met to this end:

• 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 II medical device.

• Vigilance and Post Market Surveillance. (affix ce marking approval & market the products)

The conformity assessment routes for Class III Medical Devices

 

In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:

1. follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); or
2. follow the procedure relating to the EC type-examination set out in Annex III, coupled with:

(i) The procedure relating to the EC verification set out in Annex IV; or

(ii) The procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance).

Class III controls are similar to those for Class IIb devices but additionally require the manufacturer to submit the design dossier to the Notified Body for approval under Annex II and do not allow the Annex III/Annex VI option.

There are two routes:

1. Notified Body must carry out either an Annex II audit of the full quality assurance system (ISO 13485:2003), plus that the manufacturer must submit the design dossier to the Notified Body for approval under Annex II, or
2. Type-examination (Annex III) plus one of the two 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)

Once the manufacturer has received certification from the Notified Body he may CE mark his products and place them on the market.