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In vitro diagnostic medical devices

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In vitro diagnostic medical devices

This directive aims to ensure the free movement of in vitro diagnostic devices. It harmonises the national laws on the reliability of these products and on the protection of the health and safety of patients, users and third parties.

ACT

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [See amending acts].

SUMMARY

The Directive applies to in vitro diagnostic medical devices and their accessories.

These devices are products used for the in vitro analysis of tissues or substances (blood, specimens) from the human body. The types of analysis covered are as follows:

  • state of health;
  • congenital diseases or anomalies;
  • checking the progress of courses of treatment;
  • determining compatibility in the case of organ or blood donations.

Essential requirements

The Directive lays down the objectives or essential requirements of safety, health, design and manufacture which must be met by in vitro diagnostic medical devices when they are manufactured and placed on the market.

These devices must achieve the performances intended by the manufacturer. They must be designed in such a way as to withstand the storage and transport conditions.

Harmonised standards

Member States shall publish the national standards implementing the corresponding harmonised standards, which shall also include the monographs of the European Pharmacopoiea. Any product manufactured in accordance with harmonised standards is presumed to conform to the essential requirements.

Conformity procedures

All devices must be subjected to a conformity assessment procedure. Member States shall designate independent bodies contributing to the application of these procedures for devices other than those which represent a minimal risk.

Placing on the market and free movement

Member States shall take necessary steps to ensure that devices may be placed on the market and put into service only if they meet the requirements of this Directive and do not compromise the safety and health of patients, users and other persons when properly implanted, maintained and used in accordance with their intended purposes.

Member States not must not impede the placing on the market, free movement and putting into service of devices meeting the essential safety criteria set out in the annexes to the Directive and bearing the CE mark.

European databank

The aim of the European databank is to store the data required by law. The latter shall be made available to the competent authorities and shall contain:

  • data on registration of manufacturers;
  • data relating to certificates issued, amended, suspended, withdrawn or refused;
  • data obtained in accordance with the vigilance procedure;
  • data on clinical investigations.

Vigilance

The manufacturer must immediately inform the competent authorities of any incident causing death or damage to the health of a patient, by applying the procedures of a technico-vigilance system. This information must be recorded and evaluated by Member States.

Surveillance

Notified bodies shall be authorised to carry out inspections of manufacturers. For their part, manufacturers must provide the inspectors with all relevant information.

Safeguard measures

Member States must take all appropriate measures to withdraw from the market devices conforming to the Directive which are liable to compromise the health and/or safety of patients, users or third parties. The provisional measures taken must be notified to the Commission.

REFERENCES

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 98/79/EC

7.12.1998

7.12.1998

OJ L 331 of 7.12.1998

Amending act(s)

Entry into force

Deadline for transposition in the Member States

Official Journal

Regulation (EC) No 1882/2003

20.11.2003

-

OJ L 284 of 31.10.2003

Regulation (EC) No 596/2009

7.8.2009

-

OJ L 188 of 18.7.2009

Successive amendments and corrections to Directive 98/79/EC have been incorporated into the basic text. This consolidated version is for information only.

RELATED ACTS

Notified bodies

The NANDO database will enable you to find the European notified bodies as well as third country bodies which are responsible for carrying out the conformity assessment procedures referred to in the New Approach directives.

Common technical specifications:

Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices [Official Journal L 131 of 16.5.2002].

This Decision sets out common technical specifications to replace the former specific provisions in the Member States, which mainly concerned devices used for evaluating the safety of blood supply and of organ donation. The technical specifications in this Decision relate to medical devices used for determining blood groups or for detecting and confirming HIV infection or hepatitis, amongst others.

See consolidated version

Commission Recommendation 2013/473/EU on the audits and assessments performed by notified bodies in the field of medical devices. [Official Journal L 253 of 25.9.2013].

To verify the continuous compliance with legal obligations, notified bodies should perform unannounced audits to CE-certified manufacturers, in addition to product assessments and quality system assessments.

Last updated: 29.04.2014

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