MEDICAL DEVICE NATIONAL REGISTRATION
What is National Registration?
In Article 14, “Registration of persons responsible for placing
devices on the market”, of the Council Directive 93/42/EEC of 14 June 1993 concerning
medical devices”. In paragraph 2 it is indicated that ‘Where a manufacturer who
places a device on the market under his own name does not have a registered place
of business in a Member State, he shall designate a single authorised representative
in the European Union. For devices referred to in the first subparagraph of paragraph
1, the authorised representative shall
inform the competent authority of
the Member State in which he has his registered place of business of the details
referred to in paragraph 1.
In paragraph 1 it says, ‘Any manufacturer who, under his own name,
places devices on the market in accordance with the procedures referred to in Article
11 (5) and (6) and any other natural or legal person engaged in the activities referred
to in Article 12 shall inform the competent authorities of the Member State in which
he has his registered address of business and
the description of the devices
concerned.
We can help your national registration
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• Registers your devices with the national Competent Authorities
before they are marketed.
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• Maintains a current copy of your Technical File available
for inspection by the European Competent Authorities.
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• Acts as your primary contact point for all national Competent
Authorities.
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• Interact between you and the national Competent Authorities.