Medical Device Directive 93/42/EEC (MDD)

The EU Medical Device Directive (Directive 93/42/EEC) respectively has been one of three European directives for medical devices. It is often abbreviated as MDD or 93/42/EEC.

1. EU Medical Device Directive: Basics

a) Role in the EU legal system

The European states had to transpose this EU directive – like all other directives – into national law, which Germany, Austria, and Switzerland had done with the so called “Medizinproduktegesetzen” and the “Heilmittelgesetz.”

b) Objective of the Medical Device Directive

The main objectives of the Medical Device Directive MDD were to

1. ensure the free movement of medical devices in Europe (see, e.g., Articles 2 and 4) and
2. allow only safe devices that meet uniform EU requirements (see, e.g., Article 3 and Annex I).

c) Structure of the MDD

The MDD contained 23 articles (compared to 123 in the MDR) and 7 annexes.

c) Amendment of 93/42/EEC by 2007/47/EC

The Medical Device Directive MDD was numbered 93/42/EEC because it was the 42nd directive published in 1993. It remained unchanged until 2007.

Directive 2007/47/EC supplemented and amended the MDD and the two other directives relevant to medical devices, the IVDD and AIMDD. These amendments include

• the clarification that software (also standalone) can be a medical device,
• the then-new requirement for software life-cycle processes, and
• the requirements to also consider risks due to lack of usability in risk management.

The amended directive still had the number 93/42, so you had to be careful whether you were working with the original Medical Device Directive or the consolidated version of the Medical Device Directive!

2. Requirements of the Medical Device Directive

a) Essential requirements, technical documentation, and harmonized standards

These EU-standard requirements for medical devices, described in Annex I, are referred to in the Medical Device Directive as the essential requirements. Examples of these requirements are

• risk management and thus proof that the benefits outweigh the risks,
• the usability of medical devices,
• the life cycle processes according to which software is to be developed, verified, and validated, and
• the electrical and mechanical safety of the devices.

To allow an assessment of whether these essential requirements have been met, manufacturers must document the devices and their development in the technical documentation (also known as the product file or technical file).

The directive encouraged manufacturers to apply standards to prove that they meet these essential requirements. Articles 5 to 7 concern these “harmonized standards“.

b) CE marking, classification, and conformity assessment procedures

The manufacturers affix the CE mark to their medical devices in accordance with Article 17, thereby declaring (!) conformity with the essential requirements of the Medical Device Directive (93/42/EEC). However, they must first undergo a conformity assessment procedure.

The conformity assessment procedures available for selection depend on the class of the medical device in accordance with Article 9 and Annex IX. The Medical Device Directive 93/42 describes these variants in Article 11 and Annexes II to VII.

The technical documentation content does not differ significantly between the different conformity assessment procedures. However, the conformity assessment procedure, according to Annex II, requires a complete quality management system.