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IVD Directive (IVDD): CE Marking

IVD Directive (IVDD): Ensuring safe, high quality medical devices.

CE Marking with Lloyd's Register (LR) to the IVDD ensures your In Vitro Diagnostic Devices  meet current regulatory requirements.

Overview

In order to place In Vitro Diagnostic Medical Devices (IVDs) onto the EU market, manufacturers must comply with the IVDD (98/79/EC). Currently, many IVD manufacturers can self-declare that their products meet the requirements, allowing them to be placed on the market.

With the publication of the In Vitro Diagnostic Device Regulation (IVDR) in May 2017, the regulatory landscape within the medical devices industry is undergoing significant change. The majority of IVD products that were once self-certified will now require conformity assessment by a notified body. 

Certificates issued under the IVDD during the IVDR transition period (26 May 2017 – 25 May 2022) are valid for up to two years from the date of issue.

Certificates to the new IVDR can be issued from a designated notified body, with designation expected to take place between 26 Nov 2017 and 26 May 2019. 

What we offer

Lloyd's Register (LR) is a designated notified body under the IVDD for the full range of Annex II and self-test devices. We can perform conformity assessments under the following IVD Directive 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

Depending on the type of device to be certified, these assessments can involve: 

  • Assessing your company's quality system
  • Conducting design dossier examinations for Annex II, List A devices
  • Verifying that your technical documentation meets the requirements of the directive and is implemented within the system
  • Carrying out verification of manufactured batches of Annex II, List A devices 
  • Conducting continued surveillance of your quality system

What are the benefits?

A prerequisite for trade
The IVDD introduced for the first time common regulatory requirements within the European Economic Area. It specifically deals with the safety, quality and performance of in vitro diagnostic medical devices, aiming to ensure they are safe for use and meet the performance levels specified by their manufacturer.

Why choose LR?

Technical Expertise
LR has been a leading notified body for over 20 years and is independently accredited by the relevant accreditation bodies to provide CE Marking to MDD 93/42/EEC and IVDD 98/79/EC. We are actively shaping the medical regulations through our experts’ participation in the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) technical committees and associations.

We also provide input to regulators, including the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK regarding the development of regulatory policies. LR is currently working towards having a full scope as a notified body under the new regulations.

Your business helps LR to help others
The profits we generate fund the Lloyd's Register Foundation, a charity that supports engineering-related research, education and public engagement around everything we do. All of this helps us stand by the purpose that drives us every single day: working together for a safer world.

Independent & Impartial

We maintain our independence and impartiality by proactively managing conflicts of interest across all LR businesses including those which may exist between consultancy and third-party certification services.  We will not offer consultancy services for any management system that is in the process of or has completed accredited third-party certification with LR. Further, if we are already providing consultancy services relating to a management system, we will not offer any accredited third-party assessment services.

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