PeploBio provides a streamlined approach for obtaining UK Conformity Assessed Marking (UKCA) for both molecular, serological and antigen-based assays which are required too fulfil the technical criterion by the derived EU legislation.
PeploBio provides a streamlined approach for obtaining UK Conformity Assessed Marking (UKCA) for both molecular, serological and antigen-based assays which are required too fulfil the technical criterion by the derived EU legislation. Directive 90/385/EEC on active implantable medical devices (EUAIMDD) Directive 93/42/EEC on medical devices (EUMDD) Directive 98/79/EC on in vitro diagnostic medical devices (EUIVDD)In a post-Brexit market, the EU-UK Trade and Cooperation has never been more important, and challenging. As a UK-registered CRO, and wealth of experience carrying out assay validations involving CE-IVDR and CTDA, we can facilitate UKCA product marking solutions for our customers leverage into the UK/EU market. We offer complete end-to-end support from sample logistics and processing to data management and technology where necessary.
In a post-Brexit market, the EU-UK Trade and Cooperation has never been more important, and challenging. As a UK-registered CRO, and wealth of experience carrying out assay validations involving CE-IVDR and CTDA, we can facilitate UKCA product marking solutions for our customers leverage into the UK/EU market. We offer complete end-to-end support from sample logistics and processing to data management and technology where necessary.
Until 1st of July 2024, CE-marking will continue to be recognised in the UK. As of 1st of July 2024, all medical devices must receive a UKCA before being place on the UK market. All medical devices, including in vitro diagnostic medical devices, will need to appoint a single UK Responsible Person for all your devices who will act on your behalf to carry out tasks.
A comprehensive clinical evaluation report is produced, which details the performance parameters of sensitivity, specificity, and limit- of-detection (LOD) will be provided along with data from a gold standard comparator assay. Established partnerships enable our laboratory to source retrospective or prospective samples that meet the Ct stratification requirements, at a timescale that meets your project timeline.
Our scientists are experts in both molecular and serology-based tests, ensuring that you are fully informed and confident that your project will be managed by professionals who understand the science. A detailed study plan, describing all aspects of the study design, regulatory compliance, methodology, data, acquisition, analysis, and reporting will be provided prior to study initiation. Due to our SOP-driven processes, we are able to manage large scale studies whilst maintaining the necessary quality, sample management and tracking procedures.
Read more about UKCA Clinical EvaluationTo find out more about this service or to request a service proposal, please get in touch with our R&D team at development@peplobio.co.uk and provide a copy of your technical documentation - Instructions For Use (IFU) documentation.
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.