European Directives 93/42/EEC and 2007/47/EC

European directive 93/42/EEC, as amended by European directive 2007/47/EC that came into force on 21st March 2010, covers medical devices of all types. Compliance with the directive is mandatory; it…

ISO 13485

ISO 13485 shares many similarities with ISO 9001, but is a separate standard. Whereas it also specifies the essential requirements for a Quality Management System, it is specific to companies…

NF EN ISO 4074

This international standard has been harmonised into European and then French law. It specifies the requirements and test methods for natural rubber latex condoms for men. In order to meet…

NF EN 980

EN 980 is a European standard, transposed into French law, which specifies the symbols used to label medical devices. The graphical symbols are intended for use in the information provided…

NF S97-034

The French NF S97-034 standard is a reference system for the testing of additional lubricants and other medicinal and non-medicinal preparations intended or likely to be placed in contact with…

NF EN ISO 10993

The NF EN ISO 10 993 series of international standards, transposed into French law, specifies the tests for the biological evaluation of medical devices. 10993-1 sets out the general requirements; 10993-5…

NF 062 (French NF regulation)

The French NF062 regulation is not a standard, nor is it mandatory. It sets out the steps that have to be passed in order for condoms to be attributed the…

ISO 22716, Directive 76/768/EEC and Regulation 1223/2009

These 3 statutory instruments relate to cosmetic products. ISO 22716 sets out the good manufacturing practices for cosmetics; EU Directive 76/768/EEC is the European regulation on cosmetic products; it will…

Directive 86/686/EEC

This directive covers Personal Protective Equipment (PPE), and, as with medical devices, specifies the essential requirements that the actual products and the manufacturer have to meet in order for the…

Directive 98/79/EEC

Directive 98/79/EEC relates to in vitro diagnostic medical devices (IVDMD) such as pregnancy test kits and self-test breathalysers. It specifies the essential requirements that must be met in order to…