• Wish to place a new in vitro diagnostic medical device on the European market?

  • Unsure about the product classification?

  • Need to identify an appropriate conformity assessment route to the CE mark? 

  • Concerned about selecting a Notified Body?

  • Need to prepare the Technical File?

  • Need to comply with post-market requirements?

  • Concerned about the forthcoming directive 'recast'?

 

 
All In Vitro Diagnostic medical devices (IVD) placed on the market in Europe must comply with Directive 98/79/EC, and carry the CE mark as the legal indication of compliance.
 
 
‘CE’ is an abbreviation of 'Conformité Européenne', and may be found on many other items to indicate compliance with the European directive or directives that apply to that specific type of product including, amongst others, machinery, electrical/electronic equipment, pressure vessels and personal protective equipment. The CE mark allows the products to be marketed in the EU without trade restrictions.
 
 
The aim of the IVD Directive is to guarantee the health and safety of patients and users, ensuring that manufacturers satisfy the Essential Requirements of the Directive (found in Annex 1) and demonstrate their products are safe and perform as intended.
 
 
The Directive defines an IVD as:
 
 
“any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
 
 
  • concerning a physiological or pathological state, or

  • concerning a congenital abnormality, or

  • to determine the safety and compatibility with potential recipients, or

  • to monitor therapeutic measures.”

 
 
In accordance with the Directive IVDs fall into one of the following categories:
 
 
  • Annex II List A devices (high risk devices, e.g. IVDs for the determination of HIV, HTLV, Hepatitis B,C,D and some blood grouping products including those used to test donated blood.

  • Annex II List B devices (medium risk devices, e.g. IVDs for the determination of Toxoplasma, Rubella, Citomegalovirus, Chlamydia, PSA, self-test devices for blood glucose control)

  • Other devices or “No Annex II, No self-testing devices” (low risk)

  • Self-testing devices intended to be used by lay-persons (e.g. pregnancy test kit) 

 
 
For the IVDs included in the Annex II list A and B and for the self-testing devices a Notified Body should be involved in the CE marking assessment. For general devices the manufacturer self-declares conformity and does not require a Notified Body.
 
 
Once your device is on the market, additional requirements apply in relation to the reporting of adverse incidents to the Competent Authorities designated by each EU member state.
 
 
GEMAR can help your company comply with these often complex European requirements, including answering questions such as:
 
 
  • Is my product an In Vitro Diagnostic Medical Device?

  • If so, what is its classification?

  • How do I show it complies with the Essential Requirements?

  • How do I construct a Technical File?

  • What must I do to meet the risk management requirements?

  • Does compliance with international/national standards help?

  • Do I need a Notified Body?

  • If so, how do I select one?

  • Do I need a certificated quality management system?

  • Does my device labelling meet the requirements?

  • What do I need to do if I manufacture kits?

  • What should be included on my Declaration of Conformity?

  • What are my post-market reporting obligations?

 
 
GEMAR provides a fully comprehensive service to help you market your IVDs in Europe, from simply answering one of the above questions to a significant involvement in quality system assessment, technical file preparation, including standards identification, Essential Requirements compliance, risk analysis and production documentation, together with post-market reporting.
 
 
For more detailed information on the requirements for IVD CE marking for Europe, please use the submenu in the left-hand panel.
 
 
Feel free to contact us and see how we can assist you.