Archive: Debate on IVD Directive
Unresolved issues mean that debate on the IVD Directive will continue for some time to comeThe grey areas of the In Vitro Diagnostics Directive (IVDD) will need to be resolved, probably by means of guidelines in the form of "Meddev" documents from the European Commission. However, in the meantime manufacturers should decide which private testing and certification companies they will use for CE marking under the directive and liaise with them as soon as possible on how these areas should be interpreted.
Ultimately resolution of the grey areas should involve input from industry. There must be co-operation between competent authorities, industry and notified bodies. Safety and quality concerns need to be balanced with the rapid introduction of new technology.
The choice of EU country to establish a place of business is very important. Manufacturers should take into account varying national requirements, including notification requirements and fees, medical vigilance, proactive compliance verification programs, legal liability and the language of documents. For example, member states will be free to impose additional restrictions of the use of some IVDs - such as home test for HIV or hepatitis.
Notification details will differ between the different member states. This is an area of the directive which is unclear. The requirement to notify information, significant changes and appropriate indications needs further definition. Registration requirements for Annex II IVDs and self tests are similarly imprecise. The directive asks for "all data allowing for identification" and "analytical and diagnostic parameters".
The level of detail implied is almost an attempt to create a separate notification file for each product. This is not practical for a database, referring to the fact that companies will have to submit information on their products for entry on the EUDAMED medical devices regulatory database.
Industry needs an interpretation document for the directive's medical vigilance requirements to define a practical approach for IVDs. The European Diagnostics Manufacturers Association has produced vigilance guidelines which have been circulated for comment by the competent authorities. These are currently with the European Commission to be considered for inclusion in a new Meddev document on device vigilance. It is not know, however, when this document will be ready for release.
The IVDD, which comes into force next June with a transition period of three and a half years, gives better definitions for "placing on the market" and "putting into service" compared with the Medical Devices Directive (MDD). However, there is still some confusion regarding exactly at what point a product is classed as "placed" on the market and "put" into service. Does a product need to be CE-marked before it is offered to the market?
The definition of accessories - which are covered under the IVDD - is also unclear. Products such as capillaries, tubes or even strips which may come into contact with the human skin are integral parts of an IVD system and must be CE marked under the IVDD. However, there may be others who argue that accessories would be better classified under the MDD.
Industry also needs a clearer definition of which devices will be considered research products and will therefore be exempted from the IVDD. In the US several products obviously used in a clinical diagnostic context have been labelled "For Research Use Only" as a way to avoid being subject to the heavy regulatory requirements of FDA. The European authorities are determined not to let a similar situation occur in Europe.
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