Performance Evaluation

IVDR Services

We are proud to offer complete IVDR services to support manufacturers through the design, development and launch phases of devices achieving IVDR certification. Our specialists across consultancy, regulatory, scientific and technical fields are here to illuminate the complexities of the process and guide you through the journey to achieve IVDR compliance, enabling your IVDs to be distributed and placed on the European market.  



In Vitro Diagnostic Regulation (IVDR)

The regulatory basis for placing IVDs onto the European market is undergoing significant change.  IVDR came into force on 26th May 2022 after a 5-year period of transition, at which time all new IVDs and Class A non-sterile devices, were required to comply with IVDR.  By the 26th May 2027 all devices must meet IVDR, and IVDD certified devices can no longer be put into service.  The aim of the regulation is to prevent country by country interpretations, make the manufacturer’s obligations clearer and to protect public health as technologies such as algorithms and softwares are increasingly utilised.   IVDR is more extensive than IVDD, often requiring further resources to implement and maintain post-market device launch.   In Vitro Diagnostic Regulation (IVDR) 2017/746


IVDR Implementation Timeline

Transitional arrangements have been established to facilitate meeting the IVDR requirements, whilst the regulatory infrastructure is being implemented.


Key Changes of IVDR

The most significant changes that manufacturers will experience when applying for IVDR certification are:

  • Rule based classification system that broadens the definition of IVDs

  • Increased Notified Body involvement

  • Identification of a responsible person for regulatory compliance

  • Appropriate quality management system (QMS)

  • More rigorous requirements for clinical evidence and post-market surveillance

There is a lot to consider and the transition to IVDR will require an enormous amount of work during design, development and market launch stages.  Having an IVDR strategy to meet the notified body conformity assessment and post-launch obligations is essential to continue to sell your products in the future.


Our IVDR Services

PeploBio offers regulatory consulting to streamline the process to get your devices IVDR compliant before the transition arrangement period ends.

  • IVDR Strategy

    • GAP analysis

    • Project management

    • Notified Body Selection

    • IVDR implementation strategy support

  • Design

    • Subject expert advice on Study design and formulation of the study plan to meet IVDR

    • Design and training for implementation of QMS

  • Pre-market launch

    • Performance evaluation report

    • Technical file preparation

    • QMS implementation

    • Notified body conformity assessment

    • Country specific registration

  • Post-market Launch

    • Post market surveillance

    • UK responsible person

    • Audit support

    • Continued compliance support

Contact us to find out more

We are here to answer your questions, discuss potential collaborations, and explore how our our solutions can benefit you.
Contact us

UKAS Accredited

PeploBio is a UKAS accredited Medical Laboratory No. 22998. Our UKAS accredited ISO:15189 laboratory has robust quality processes in place, essential for supporting drug and vaccine discovery, validation, and development.


We are ICO registered organisation with clearly defined data privacy policies, and robust data protection systems to ensure third party patient data remains protected.