Ensuring all relevant product information is communicated clearly is an extremely important part of the compliance and market entry process for medical devices. As a general rule of thumb, any information pertaining to the product and its intended use should be outlined in at least the native language of every country on the European Market it is being released to.
The compliance process, however, can sometimes be complex or confusing. In an effort to make each step of the process as transparent as possible, the European Commission introduced a series of (mandatory) guidelines for products seeking to enter the EU market – one of which directly relates to the language requirements for a product’s instructions for use.
Under Article 4 of these guidelines, or Medical Device Directive 93/42/EEC to be precise, all information directly related to the medical device – namely the instructions for use, though also relating to labelling information, etc. – must be clearly displayed in the official language(s) of each EU member state it is intended to be sold in. While other languages are, of course, permitted, it is mandatory to have at least the basic language requirements for the entirety of the product’s core market inside Europe.
Other important guidelines within this directive include:
- Only devices with a CE marking may be promoted and sold on the European market (Article 2)
- Devices without a CE marking may be exhibited at trade fairs and exhibitions, but they must be clearly marked ‘for demo purposes only’ (Article 4(3))
- Medical devices must only be promoted in direct reference to their intended use or purpose (Article 1(2))
Medical devices may not contain any markings which may be misleading to users in any way (e.g. in reference to the intended purpose of the device or its effects, etc.)
To reiterate, under MDD 93/42/EEC, the instruction for use of medical devices being introduced to the European market must be provided in the native or official language(s) of each and every EU member state it is being sold on. Without the provision of this, the device may not be sold on the European market.
To find out more about the intricacies of the European compliance process, or to find out about Obelis’ Compliance and European Authorized Representative services and how they can facilitate your European market entry, contact our team of regulatory experts today.