Surely you have heard about it: the IVDR, the new In Vitro Diagnostic Medical Devices Regulation. Published in May 2017, it replaces the In Vitro Diagnostic Medical Devices Directive (IVDD) and brings new requirements for manufacturers. The good news is: there is a five-year transition period. But do you know how this affects you, and how you will make sure you are fully compliant by 2022? We have the expertise and experience to get you ready in time.

IVDR Analytical Performance Studies

Important ChangesWith the IVDR we will see many changes in definitions, and it also has a wider scope. This means that products currently classified as an in vitro diagnostics device (IVDD), may require IVDR compliance. The IVDR also tightens the requirements for clinical evidence and conformity assessment. Technical documentation must contain the results and critical analyses of all design verification and validation tests – data must be collected in compliance with the harmonised standards and applicable Common Specifications.

How we can help you meet new IVDR requirementsWe offer analytical performance services to ensure a smooth transition from the IVDD to the IVDR. As a first step, we will review your current technical documentation. We will determine which studies have already been reported and assess their quality. Based on this, we will come

up with tailored advice and, together, we will decide which additional studies are critical to demonstrate compliance. Then, while you as manufacturer can continue to focus on future developments, we will conduct the necessary analytical performance studies to ensure timely conformity of your assays with the IVDR.

Why choose Future Diagnostics’ analytical performance services?- We are EN-ISO 13485 certified and our studies

are designed to comply with EN 13612:2002, EN ISO 23640:2015 and applicable CLSI guidelines

- We will tell you in advance what is required to comply with the IVDR, and do exactly that – nothing more

- All your products will be IVDR compliant in time - Your team stays focused on their (development)

activities - And... you will enjoy total peace of mind

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Future Diagnostics Solutions BV offers services for the development and manufacturing of IVD (immuno) assays to IVD multinationals, mid-sized biotech and small start-up companies within the global medical diagnostics and device industry. Since 1997, more than 150 products are developed in accordance with IVD requirements and regulations (ISO13485/FDA/cGMP). The profound experience makes Future Diagnostics a trusted partner for assay development of any type of assay, with any type of technology on any type of analyzer.

Assay DevelopmentFuture Diagnostics develops high quality IVD immunoassays on demand and offers flexible support plus advice in feasibility, optimization, verification and validation projects, including technical transfer to manufacturing for third parties.

Analytical PerformanceWe offer analytical performance services to IVD (immuno) assay manufacturers for a seamless transition to the new IVD Regulation.

Point of CareWith many years of experience in quantitative POC test developments on whole blood, using dry chemistry and short assay times, we are the obvious choice to bring the lab to the patient.

Pre-FeasibilityPre-feasibility studies are of great value if the development of a specific assay is under consideration. Preliminary experiments are run with available raw materials to determine whether it is worthwhile to proceed to the feasibility phase.

(Free) Vitamin DWith a patent on the measurements of FREE 25-OH Vitamin D in blood, Future Diagnostics is leading the market with this new Vitamin D application. Furthermore we have a vast experience in Vitamin-D assay developments, either on automated platforms or manual formats.

Nieuweweg 2796603 BN Wijchen,The Netherlands

Contact us at:

phone: +31 (0)24 64 52 900info@future-diagnostics.nl

www.future-diagnostics.com

The Extension of Your

Internal R&D

IVD Assay Development & Contract Manufacturing Services