In Vitro Diagnostic Device Regulation (IVDR)

What is the In Vitro Diagnostic Device Regulation?

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 when it is published, currently estimated for Q4 2016.

Why is the IVDR necessary?

The current EU regulatory framework for IVDs consists of the IVD Directive (IVDD) 98/79/EC which as the title suggests, was last published in 1998.

Constant scientific and technological progress, substantial deviations in the interpretation and application of the rules, and the perceived lack of transparency have all led to the existing directive coming under criticism in recent years.

The new regulation aims to overcome these flaws and divergences and further strengthen patient safety via a robust, transparent and sustainable regulatory framework that is ‘fit for purpose’.

What does the regulation cover?

It applies to all in vitro diagnostic device (IVD) manufacturers who intend to place their products in the European Economic Area, whether they are designed and/or manufactured within or outside the European Economic Area.

LRQA as a Notified Body

LRQA has been a leading Notified Body for over 20 years, and is independently accredited by the relevant accreditation bodies to provide CE marking to both existing directives - Medical Devices Directive (MDD) 93/42/EEC and In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC.

We are currently working towards having a full scope as a Notified Body under the new IVDR.

CE Marking

We can perform product conformity assessment and certification activities against the existing IVDD 98/79/EC, including:

  • Auditing
  • Design dossier - conducting design dossier examinations of Annex II 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

Why choose LRQA?

Get it right the first time, on time 

To win in the highly regulated and high stakes world of medical devices manufacturing, it is crucial to beat the competition to the market, and minimise any potential losses from surprise product launch delays.

Our thorough yet streamlined approach ensures you get the right type of guidance at any stage of the product lifecycle, towards a timely market launch.

Our expertise

As a leading Notified Body with more than 20 years’ experience in the medical arena, LRQA is actively shaping the medical directives and associated harmonised standards through our experts’ participation in the MDD and IVDD technical committees and associations, such as European Forum of Notified Bodies Medical Devices (NB-MED) and British In Vitro Diagnostics Association (BIVDA).

LRQA helps to unlock the power of your management systems to improve organisational performance and reduce risk. We also provide input to regulators such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

To find out more about how LRQA can help you with your requirements, email us at enquiries@lrqa.com.

Medical Devices Regulation (MDR)

We know medical devices

LRQA can help take the uncertainty out of the changing medical device regulations and associated standards and schemes. Learn about our CE Marking, ISO 13485:2016, MDSAP services and more.