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The IVD Directive and the MDD

On December 7, 1998 the European Union adopted directive 98/79/EC on in vitro diagnostic (IVD) medical devices.  This directive joins the active implantable medical device and medical device directives to provide a uniform set of requirements for all types of medical devices across the European Union.  The IVD directive not only spells out the requirements for IVD’s, it also makes some amendments to the medical device directive (MDD).  Since the MDD amended the active implantable medical device directive (AIMD) the changes to the IVD also impact the AIMD.  The specific requirements for IVD’s will be reviewed in a future issue of update.  The changes that impact products covered by the MDD are as follows.

The first change replaces the existing definition of an IVD device in the MDD with a updated one that matches the wording in the IVD directive.  While having no direct impact on medical devices, it does ensure that the defintion of medical and IVD devices is consistent between directives so the proper directive is selected for CE marking.

A new term is defined. Although used throughout the MDD, the term authorized representative is not defined in the existing MDD. This is now defined as "any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer...."  This really adds nothing new, but just finally defines what has been expected all along.

Article 2 of the MDD is replaced completely with a revised section that covers placing devices on the market and putting into service. The term "putting into service" is redefined Putting into service – means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose.  The wording "has been made available to the final user" has been added to clarify the previous
definition.

Also added to article 2 is the statement that "Member States take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose."  The reference to the requirements of the Directive replace "if they do not compromise the safety and health of patients, users and, where applicable, other persons".  It means also that each Member State can ask for notification of any class of medical of medical devices sold in its' territory.

Article 14(1) is amended with an important addition. Each country may now request the manufacturer inform them of the  identification, labeling and instructions for use for class IIb and III devices when they are put into service in that country.  Article 14 already requested the notification of Class 1 products, and the designation by the non European Manufacturers of a responsible person in the community.  This addition confirms the Article 2 comments.  In fact, notification of Classes III and IIb products was already applied by some countries such as Spain.  In theory this should limit countries to just these requirements. 

A new article 14a is added that created a European databank for the competent authorities.  The databank will contain registration of class I manufacturers, certificates issued changed or withdrawn by notified bodies, and vigilance data.  The databank should allow the competent authorities to do their job in a more efficient manner.  The creation of a European Databank may also limit the requests of the Member States in term of notification and information as seen in the previous articles.  Lack of communication between Member States has been experienced until now.  Main reasons are limited number of people within Competent Authorities and the barrier of languages. Manufacturers, Authorized Representatives and Notified Bodies will be responsible to provide the data.

Another addition is article 14b.  It strengthens each countries ability to take action on devices that it considers to be a threat to public health and safety.  It allows the authorities to prohibit, restrict or subject it to particular requirements.  The country must inform the EC commission and all other member states and provide the reason.

Article 16 has a few additions as well.  Notified bodies are now required to inform other notified bodies and competent authorities about any certificates suspended or withdrawn.  They must also on request provide information about certificates issued or refused.  This has been done in some cases, but was not formally required.  A notified body must now withdraw or suspend certificates when the requirements of the directive are not being met.  This was previously inferred, but is now spelled out.  The notified body may involve the competent authority if needed.

Article 16 also now allows the competent authority access to any information needed to verify that a notified body meets the requirements listed in Annex XI of the MDD.  This even includes budgetary data to ensure proper resources are available or that there are no conflicts of interest.

A provision has been added that allows enforcement of the directive not only on medical devices that are not CE marked according to the directive, but also to products CE marked under the MDD that the MDD is not applicable to.  This could affect issues such as CE marking a cosmetic item under the MDD or similar misapplication of the directive.

The grace period for MDD medical devices that were in the distribution channel prior to June 13, 1998 is formally adopted.  Thus a device that was placed on the market prior to June 1998, but not yet put into service may still be put into service by June 30, 2001.  This would affect products that a manufacturer has sold to a distributor, that have not yet been put into service.

The IVD directive does not start its transition until June 7, 2000.  It will become mandatory on December 7, 2003.  The changes to the MDD will formally begin to take effect when each country  transposes the IVD directive into country law. In theory this would be by June 7, 2000.  Based on past experience most countries will not transpose it until sometime during the transition period.   Manufacturers with devices covered by the MDD should probably consider these changes as being in effect and address them as needed. 

Contact us if you would like a copy of the IVD Directive or the MDD.