CE marking is a legal requirement for medical devices intended for sale in Europe.
There are three European CE marking Directives that specifically apply to medical devices manufacturers:
- The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive
- The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices and related accessories intended to be permanently implanted in humans
- The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions.
BSI is designated as a Notified Body with a comprehensive scope under the MDD and the AIMD and can provide the full scope of services under the IVD Directive via a Notified Body partner. These services include:
- Technical documentation/file or design dossier assessment/review
- Device type examination
- Product quality assurance (based in ISO 13485)
- Production quality assurance (based in ISO 13485)
- Full quality assurance (ISO13485)
- Batch verification/release
A complete set of Notified Body CE marking Guidance Documents is available to download from the BSI website.
For further information BSI's schemes and services for medical devices in Europe, please contact us.
Source
In Vitro Diagnostic (IVD) Medical Devices Directive
98/79/EC
What is the In Vitro Diagnostic (IVD) Medical Devices Directive?
The IVD Medical Devices Directive is relevant to you if you design, manufacture or distribute IVD medical devices within the European Economic Area.
What does the In Vitro Diagnostic (IVD) Medical Devices Directive cover?
An in vitro diagnostic medical device is defined by the IVD Directive as "any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients".
Examples could include:
HIV test kits
blood gas analysers
home use pregnancy tests
blood collection tubes and specimen containers
multi-analyte control sera
immunoassay analysers and reagent kits
blood glucose monitors for diabetics
Information on the directive and a copy of the directive text can be found on the European Commission website.
LRQA services
LRQA is designated as a notified body under the IVD directive for the full range of devices, under the following Annexes:
- Annex III - Design examination for self-test devices
- Annex IV - Full Quality Assurance
- Annex VII - Production Quality Assurance
Certification - LRQA delivers product conformity assessments and certification which includes:
- Auditing - a company's quality system
- Design dossier - conducting design dossier examinations for List A devices
- Verification - verifying that your technical documentation meets the requirements of the directive and is implemented within the system
- Verification - carrying out verification of manufactured batches of defined high risk IVDs
- Continued surveillance - conducting continued surveillance of the quality system.
Next steps...
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