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European Regulatory Support for Business since 1995
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CE Marking, Health & Safety . . .
Risk Management, Product Safety . . .

If you are managing sterile medical devices ensure that biocompatibility studies to EN10993 have been undertaken.

Many medical devices and specifically those that come into contact with a patient’s body are subject to biological and biocompatibility testing. This testing is to assess the interaction between body fluids, tissue or cells with the device in order to protect the patient from potential risk. Risk includes toxicity and irritations – tests are dependent on how long the device is in direct contact with a patient, the type of device as well as what it is made from.

If you are in any doubt about your device and the EN10993 directive Atlantic Bridge can help you work through the necessary processes and procedures.

Many businesses have subscribed, often unknowingly, to unregistered assessment companies for ISO9001 certification and obtained little more than a low value certificate which can lead to a loss of credibility in the eyes of potential customers who better understand the process of accreditation.

  • The BS EN ISO9000 series of standards has been the topic of more discussions than most other standards combined. Now there is only ISO9001 which can be certificated.
  • Many businesses have implemented the standard due to client pressure or because of benchmarking with their competitors.
  • Benefits of implementing the ISO 9001 can be considerable, in particular the opportunity to ensure company systems are working and delivering the proof that product and service provided meets the requirements of the business and the expectations of the customer.
  • Many European Directives covering products require Quality Systems to underpin the “CE” Mark.

All class 1 Medical Device Manufactures must remember the need to ensure they comply with the Directive to maintain legality of supply. Failure to do so could result in product recall, product withdrawal from the market and damage to the manufacturers brand.

This requires risk management documents, clinical evaluations, essential requirements matrices, processes in place to comply with the relevant Medical Devices Directive and MEDDEVs.

Remember if they are supplied sterile or include measurement facilities they require a Notified Body to approve prior to being legal to sell in the EU.

For further detailed information from the MHRA website follow this link -

If you have any concerns about your products contact Atlantic Bridge who will be able to give you clear and informative guidance and information.