Firstly the manufacturer needs to consider that the product falls within the scope of the Directive.
The manufacturer's products must meet all of the relevant essential requirements contained in Annex I of the Directive. This will include amongst others, as relevant:
- Risk management
- Performance evaluation
- Sterilization
- Electrical safety
- Electromagnetic compatibility
- Labelling and instructions
Where available relevant standards may be used to demonstrate how many of the requirements have been met.
In addition manufacturers will need to determine the classification of their products. Once this has been determined they will need to follow the appropriate conformity assessment procedure. This may require them to have their quality systems and technical documentation reviewed by a Notified Body before they can place their products on the market. For the highest risk products the Notified Body will need to release each product on a batch-by-batch basis. The body will need to assure itself that relevant requirements have been met before issuing relevant certification. Manufacturers can then place the CE marking on their products to demonstrate their compliance with the requirements.
The Irish Medicines Board has produced some useful guidance for manufacturers of IVDs falling within the 'general' class of products requiring no Notified Body intervention (external link).
All manufacturers of IVDs are required to register their products with the relevant authorities.
