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In Vitro Diagnostic Devices Directive (IVDD) (98/79/EC)

IVDD: Ensuring safe, high quality In Vitro Diagnostic 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. 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

LR recognises that every organisation and its processes are unique. Compliance with the current medical device directives will depend upon the complexity of your organisation and implementation of processes to meet the requirements. At LR, we take time to understand the needs and unique circumstances of our clients and their businesses, to act with judgement, sensitivity and care. Our independence means that we’re committed to doing things the right way to reach the highest standards and best outcomes for all, giving our clients confidence in our decisions every time.

Assessment
We specialise in conformity assessment services and CE Certification for medical devices. The two-stage certification process for CE marking ensures you have a quality system that meets the requirements of the relevant directive and is underpinned with expert advice designed to meet the needs of your industry. We explore every problem thoroughly with exact, analytical precision. We leave no stone unturned and no questions unanswered, to draw accurate conclusions.

If you manufacture or distribute medical devices within the European Union, you will have five years from 25 May 2017 to transition to the new IVDR and three years to transition to the new MDR.

Training
We provide practical client training courses worldwide in various languages, led by trained and qualified tutors. Many of our courses are endorsed by relevant professional bodies and based on our experience of assessing management systems. We offer both public and in-house training services including customised training solutions.

A wide range of assurance services
Don’t let your certification journey stop with quality; at LR, we deliver certification, validation and verification assessment services to all of the world’s leading standards and schemes including health and safety, environmental, sustainability, energy management, business continuity, cyber security and many more.

What are the benefits?

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?

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.

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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