The IVD Directive (IVDD) 98/79/EC introduced the first common regulatory requirements within the EEA that deal with the safety, quality and performance of in vitro diagnostic devices.
The IVD Directive defines an in vitro diagnostic device 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.”
In May 2017, the regulatory landscape changed following the publication of the In Vitro Diagnostic Device Regulation (IVDR). The introduction as a Regulation will ensure that legal requirements are implemented consistently throughout the EU.
Route to conformity
Under the IVDD, Lloyd's Register (LR) is a Notified Body for in vitro diagnostic devices for the following annexes:
- Annex III, section 6 - Design examination for self-test devices
- Annex IV - Full quality assurance and design dossier review
- Annex VII - Production quality assurance
We can offer the following conformity assessment activities against the directive:
- Design dossier examinations for Annex II, List A devices
- Verification of your technical documentation, ensuring it meets the requirements of the directive and is implemented within the system
- Verification of manufactured batches for Annex II, List A devices
Need help with IVDD?
Our experts have a comprehensive understanding of CE marking certification within the in vitro diagnostic device sector - including the essential requirements of the IVDD.
LR’s two-phase certification process for CE marking ensures you establish a quality system that follows the IVDD guidelines and satisfies the regulatory requirements.
First, your expert assessor will establish you have appropriately identified the IVDD essential requirements which apply to your products and integrated them into your QMS. They will then ensure you have taken the required steps to create the technical documentation.
Once approved, LR will carry out frequent surveillance visits to appraise your system, sample your technical files and help you stay compliant with the IVDD requirements.
Why work with us?
Globally recognised and accredited
For the last 20 years, LR has been an industry-leading Notified Body with independent designation by the MHRA to provide CE marking to MDD 93/42/EEC and IVDD 98/79/EC. We are also accredited by United Kingdom Accreditation Service (UKAS) and Standards Council of Canada (SCC) to provide ISO 13485 certification, and by SCC and Health Canada to provide MDSAP certification.
LR is actively shaping the medical regulations and associated harmonised standards through our active participation in the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) technical committees and associations. These include the European Forum of Notified Bodies Medical Devices (NB-MED) and British In Vitro Diagnostics Association (BIVDA).
Through applying LR’s distinctive inside-out assessment methodology, our technical experts ensure they fully understand your broader business objectives to reduce operational risks and increase the effectiveness, efficiency, and ongoing improvement of your quality management systems.
We maintain our impartiality by proactively managing conflicts of interest across all LR businesses including those which may exist between consultancy and third-party certification services. Click here to learn more.
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