Implementing the EU Medical Devices Directive 93/42/EEC

Stage 2: Does the Directive apply to you?

The Directive was implemented on 1st January 1995 and became mandatory on 13th June 1998. Before June 1998, manufacturers were permitted to comply with the Directive on a voluntary basis and apply the `CE' marking as appropriate, or continue to meet the local requirements of each individual member state in the European Union (EU). The end of the transition period has now passed and compliance with the Directive is now mandatory for all medical devices

After June 1998 the 'CE' Marking took over from all other mandatory requirements for markings in the EU (whether Statutory or 'emanations of the State', e.g. 'GS') .

The Directive applies to the legally defined `manufacturer' who is `placing on the market' a medical device or accessory to a medical device, as defined in the Directive.

It should be noted that in the UK 'own branders' continue to be considered to be the legal manufacturer of the medical devices. As such they must meet the obligations of the Directive, liaise with a Notified Body and apply the 'CE' Marking as if they were the actual producer

Non EU located manufacturers must also apply the 'CE' Marking to their devices and are subject, where applicable, to a Notified Body audit.

References 93/42/EEC
Article 1:2(a) - 'medical Device'
Article 1:2(b) - 'accessory'
Article 1:2(f) - 'manufacturer'
Note: 'Own Branders' are classed as the legal manufacturer
Article 1:2(g) - 'placing on the market'
Article 1:2(h) - 'putting into service'