European Authorized Representative for Medical Devices

Having an independent third party as Authorized Representative in Europe has the following advantages:

• Change of distributor has no influence on the product labels;

• Totally focused on regulatory affairs of medical devices, not on sales;

• No conflict between regulations and sales interests;

• No disclosure of product confidential information to your distributor.

Basic Services:

• Offering the company name you print on your CE–marked medical device and related printed materials such as labels, manuals and websites;
  

• Register your Class I medical devices with the Dutch Competent Authorities, as BioTop Medical is a Dutch company, and register your device with the Competent Authorities of other EU Member States where your product is distributed in case of In Vitro Diagnostic Medical Devices;
  

• Keep the CE Master File of your product available to the Competent Authorities, on request;
  

• Keep you informed of any relevant changes in the Device Directive and the product applicable (harmonized) standards;
  

• Inform you concisely of the need of revision of the product CE Master File;
  

• Communication with the Competent Authorities, distributors, user and Notified Body (if applicable);
  

• Handover to you any complaint received regarding your product;
  

• Vigilance system: notification of the adequate Competent Authority of any  incident occurred in the EU with your product according to the latest guidelines;
  

• Coordination of any required recall.

Additional Services:

• Hands–on update of the existing CE Master File as a consequence of changes in the legislation, applicable standards or design changes (including changes in the production method and labelling);
  

• Advice on the applicable standards and requirements regarding the CE–marking of a (new) medical device;
  

• Write (update) the Risk Management File (ISO 14971:2007) and coordinate the Risk Analysis discussions;
  

• Write and compile the CE Master File for any class or type of medical device;
  

• Assist with the selection of the Notified Body and be the interface between the manufacturer and the Notified Body;
  

• Perform supplier audits, if established in the EU or visit any other site in the EU for regulatory purposes on behalf of the manufacturer;
  

• Support you with any Quality System–related issue.