Home
About MDSS
Newsletters
MDD
IVDD
AIMDD
Consulting & Support Services
Events
WWW Links
Contact MDSS

MDSS
serves clients' specific needs with changes
of products and regulations.  Each client is unique and MDSS customizes the solution for each client individually.

An over-view of the
IVDD implementation process

Europe’s regulatory requirements for In-Vitro-Diagnostics have finally been cast "in stone". The IVD Directive was adopted by the European council of Ministers on October 5, 1998 some four years later than originally expected.

It is the last of the three major directives regulating the medical device and diagnostics Industry in the European Economic Area (EEA). It will introduce a system of CE marking for manufacturers of reagents and laboratory instruments. They will either have to self-certify that their products comply with the directive, or submit them to be certified by third-party organizations, depending on the level of risk.

The IVD Directive was published in the Official Journal of the European Communities on December 7th, 1998. Member states will have 12 months from the date of publication to transpose it into national law. The first CE-marked devices will then be allowed on the market from April or May of the following year.

IVDs which conform to current national legislation may still be marketed until 2003 and put into service for a further two years.

....Industry faces opposition

The long awaited adoption of the directive is a relief for the industry. It has fought long and hard to have a single regulatory framework throughout the EEA and encountered significantly more opposition than was faced by the two medical device directives. This stemmed mainly from French demands for stricter requirements for high-risk IVD products.

The national IVD industry associations now have to ensure that the translations are accurate and the transposition is carried out correctly, said John Place, director general of the European Diagnostic Manufacturers Association (EDMA). He recommended that associations work closely with the regulatory authorities to explain industry’s interpretation of the directive.

Mr. Place added that EDMA will encourage the European Commission to set up a meeting as quickly as possible to begin work on the common technical specifications needed for the implementation of the directive. These are analyte-specific performance requirements for high-risk products to be agreed by all competent authorities.

They were introduced in response to demands from the French authorities for more stringent regulations covering high-risk IVDs than were originally proposed for the European directive.

EDMA is also concerned that the IVD industry should not be disadvantaged by being the latecomer on the European medical device database, EUDAMED, which is just coming on-line for medical devices. Manufacturers of both low- and high-risk diagnostic products will be obliged to ensure product information is available to all competent authorities on this database. EDMA will now concentrate on promoting the cost benefits of laboratory testing.

Return To Previous Page