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.
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
Transitional arrangements have been established to facilitate meeting the IVDR requirements, whilst the regulatory infrastructure is being implemented.
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.
PeploBio offers regulatory consulting to streamline the process to get your devices IVDR compliant before the transition arrangement period ends.
Notified Body Selection
IVDR implementation strategy support
Subject expert advice on Study design and formulation of the study plan to meet IVDR
Design and training for implementation of QMS
Performance evaluation report
Technical file preparation
Notified body conformity assessment
Country specific registration
Post market surveillance
UK responsible person
Continued compliance support
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