Legal Manufacturer
A legal manufacturer is any natural or legal person who is responsible for designing and manufacturing a product with a view to place it on the Community market ‘under his own name’ (or trademark).

The legal manufacturer is responsible that the medical device complies with the essential requirements as stated in Annex I of the MDD, ensuring that they do not compromise the health and safety of patients, users and any other person and that the medical device performs as intended by the manufacturer.
Medical Devices bear the CE mark to indicate their conformity with the MDD.
Where sub-contracting takes place, the manufacturer must retain the overall control for the product and ensure that he receives all the information that is necessary to fulfill his responsibilities.


Certifying Body
A Certifying Body is an organization that has been accredited to assess whether a QMS meets certain standards e.g. the ISO-13485.


Notified Body
A Notified Body is an organization that has been accredited to assess whether a product meets certain standards e.g. the MDD.


Competent Authority
The government of each EU Member State must appoint a competent authority responsible for medical devices. The competent authority (CA) is a body with authority to act on behalf of the member state government to ensure that member state government transposes requirements of medical device directives into national law and applies them. The CA reports to the minister of health in the member state.
In The Netherlands  the ‘Inspectie voor de Gezondheidszorg’ (IGZ) acts as a CA.
In the EU, all medical devices must be identified with the CE mark.


Raad van Accreditatie
The primary task of the RvA is to verify that institutions active in the field of laboratory testing, inspections, calibration and certification, meet the accreditation standards. For this the RvA is using international (ISO) and European standards (EN). Since 1 January 2008 the ‘Organisatie voor accreditatie van medische laboratoria’ (CCKL) has been merged with the RvA.

The working method of the RvA is controlled by international accreditation institutions through peer reviews.