Special attention is required for medical devices before they are brought onto the European market. These MDs (medical devices) must obtain a CE label issued by a notified body.
LCIE Bureau Veritas supports you in the validation of your electro-medical devices.
This CE marking or label signifies compliance with all applicable Directives. The main safety and performance requirements applicable to medical devices (MD) are described in Directive 93/42/EEC (amended in 2007), which will become obsolete in May 2021, and will give way to European Regulation 2017/745 on MDs., applicable starting May 26th, 2021.
However, MDs may need to respond to other guidelines:
- Regulation 2017/745/EU relating to medical devices (MDR)
- Directive 90/385/EEC applicable to Active Implantable Medical Devices (or AIMD)
- Directive 98/79/CE applicable to In Vitro Diagnostic Medical Devices, (or IVDMD)
- RED (2014/53/EU), applicable to MDs equipped with radio modules
- ROHS (2011/65/EU), already applicable to certain MDs
Directive 93/42/EEC defines 4 classes of MD (I, IIa, IIb and III) according to the risk inherent in the technological characteristics of the device and its mode of use. The higher the risk, the higher the class of the device and therefore, the stricter the evaluation and control rules.
OUR COVERED AREAS
Accredited for a wide set of electromedical standards, LCIE Bureau Veritas makes its expertise available to manufacturers, distributors and importers of electromedical devices. In addition, LCIE Bureau Veritas participates in specific standard committees (Member of the UTE).
We are present in Europe, but also internationally, thanks to the global Bureau Veritas laboratory network.
All electronic and electrical devices pose risks to people, the environment and property. In order to reduce these risks, it is essential for designers to understand the guiding principles behind safety requirements so that they can produce safe materials.
To check the safety requirements of your medical devices, LCIE Bureau Veritas offers you its electrical safety and electromagnetic compatibility test facilities, allowing you to cover all the technical requirements described in the applicable standards.
- Electromagnetic compatibility
- Electrical safety
- Eco-environment (analysis of hazardous substances, life cycle analysis)
- Electromagnetic Fields (EMF’s)
- Mechanical and climatic
REGULATIONS AND APPLICABLE STANDARDS
- IEC / EN / NF 60601-1 (ed.2); am.1; am.2
- IEC / EN / NF 60601-1 (ed.3)
- IEC / EN / NF 60601-1-x
- IEC / EN / NF 60601-2-x
- IEC / EN / NF 61010-1
- IEC / EN / NF 61010-2-x
- ELECTROMAGNETIC COMPATIBILITY
- IEC / EN / NF 60601-1-2 (ed. 2 and 3)
- IEC / EN / NF 61326