Harmonisation of law in the context of "Directive 93/42/EEC"

Play Trivia Questions online!

 or

Skip to study material about Harmonisation of law in the context of "Directive 93/42/EEC"

⭐ Core Definition: Harmonisation of law

In the European Union, harmonisation of law (or simply harmonisation) is the process of creating common standards across the internal market. Though each EU member state has primary responsibility for the regulation of most matters within their jurisdiction, and consequently each has its own laws, harmonisation aims to:

  • create consistency of laws, regulations, standards and practices, so that the same rules will apply to businesses that operate in more than one member state, and so that the businesses of one state do not obtain an economic advantage over those in another as a result of different rules.
  • reduced compliance and regulatory burdens for businesses operating nationally or trans-nationally.

An objective of the European Union to achieve uniformity in laws of member states is to facilitate free trade and protect citizens.

↓ Menu

In this Dossier

Harmonisation of law in the context of Medical Devices Directive

The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010.

The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.

↑ Return to Menu
LINKED FROM (PARENTS)
← Medical Devices Directive ← Directive 93/42/EEC
LINKS TO (CHILDREN)
European Union → Free trade →