EC directives

EC Product Directives were created by the European Union (EU) to achieve the free movement of goods and services. The directives came about as a result of the Treaty of Rome, 1957. They are intended to remove any barriers to trade across Europe that could be caused by the multiple testing and certification of items and equipment to meet the regulations of individual EU member state markets.

Independent testing, inspection or certification of a product according to a directive must be done by a body that is approved by a government of the community and notified to the European Commission.

LRQA is an approved body and can provide independent certification to the relevant Directives that your business requires to deliver the products and services safely and of an expected standard to your customers.

We are appointed as a Notified Body for many EC Directives, including:

Medical Device Regulation (MDR)

The Medical Device Regulation (MDR) is a new regulation that will replace the existing Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC. It applies to all medical device manufacturers who intend to place their products in the European Union (EU).

Personal Protective Equipment Directive 89/686/EEC

The Personal Protective Equipment Directive (PPE) is important to you if you design or manufacture personal protective equipment which is covered by the Directive and which is put on the market within the European Economic Area.

Pressure Equipment Directive 97/23/EC

The Pressure Equipment Directive (PED) applies to you if you design or manufacture certain types of pressure equipment which is placed on the market within the European Economic Area.

In Vitro Diagnostic Device Regulation (IVDR)

The ln Vitro Diagnostic Device Regulation (IVDR) is a new regulation that will replace the existing ln Vitro Diagnostic Devices Directive (IVDD) 98/79/EC. It applies to all IVD manufacturers who intend to place their products in the European Union (EU).