Active implants are the medical devices within the higher risk categories and are regulated according to the Active Implantable Medical Device (AIMD) Directive 90/385/EEC. These medical devices must be manufactured and assessed over very rigorous controls to ensure their safety.
Manufacturers, importers and distributers must adapt their quality systems to the specific requirements of these products which are usually more demanding.
As any other Medical device, they require an Authorised Representative (EC REP) to represent the manufacturer (foreign or not) in front of the Authorities.
For each product it will be necessary to study and analyze the aspects that determine its safety and efficacy. It is always advisable to create a strategy that makes the process as efficient as possible and in the shortest possible time.
From Bionok we offer you all the necessary services to develop your Medical devices guiding you throughout the entire process:
– Design and development, for its adaptation to the regulations.
– Advice and development of clinical safety and efficacy tests.
– Elaboration of required scientific-technical dossiers.
– Quality systems.
– Presentation before authorities or evaluation centers.
– Representative or Authorized Agent.
– Place on the market.
The Unique Device Identifier (UDI) is a numeric or alphanumeric code that identifies the medical device. This code consists of 2 parts: device identifier (DI) specific to a manufacturer and a product and a production identifier (PI) that identifies the production unit of the product. Bionok can help you get the UDI code for your Medical Device.
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