EU IVDR Support & Health Institution

Almac as a Health Institution – Your faster route to EU trial enrolment

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that Almac Diagnostic Services UK laboratory in Craigavon, Northern Ireland, meets the definition of a Health Institution provided all IVDR Article 5(5) requirements are met:

Screening services for pharma-sponsored medicinal product clinical trials to determine eligibility for trial enrolment or patient stratification once enrolled on the trial, i.e. IVDs function in an interventional capacity. Samples are collected from clinical trial sites worldwide and shipped to Almac, therefore the IVD is used in the same institution (Almac’s clinical laboratory) in which it is made (although results are distributed worldwide). These IVDs meet all GSPR requirements set out in IVDR Annex I and meet all Article 5(5) requirements. It is not intended that the IVD will generate clinical performance data for submission to regulatory authorities, it will solely be used within the clinical trial.

The IVDR Challenge

Depending on the intended use of the IVD within the trial, IVDR requires Clinical Performance Study (CPS) applications to be submitted to the Competent Authority (CA) of each country in which there is a clinical trial site. The increased administrative burden and long CA and ethical committee review times can lead to delays in trial initiation and increased costs.

EU Pharma Trial approval under Almac Health Institution

Almac Diagnostic Services has successfully supported our key Global Biopharma partners EU clinical trial application as a Health Institution.

The Pharma trial has been approved, listing Almac Diagnostic Services as the Health Institution provider who will be prospectively testing samples from the trial.

This trial has been approved for testing samples from sites in 6 key EU countries: 

France
Germany
Italy
Netherlands
Poland
Spain

Further sites are pending approval.

Benefits for Pharma & Biotech Companies of utilising Almac as a Health Institution

Utilising Almac as a Health Institution means a faster and cheaper route to EU trial enrolment for your biomarker led clinical trial programmes.
Some of Almac’s own existing IVDs, and IVDs created for pharma clinical trial sponsors, may be able to be used as in-house devices within Almac as a ‘Health Institution’. For these IVDs, Almac must meet all requirements set out in IVDR Article 5(5).

For Pharma Sponsors of Clinical Trials there would be no need for IVD:

Marketing approval

Clinical Performance Study (CPS) approval

Benefits

Time: Faster Route for EU Clinical Trials Participant Enrolment
Money: Cost reduction for Trials without need to pay for CPS applications to multiple Competent Authorities

Our Almac Diagnostic Services UK laboratory provides genomic & anatomic pathology services and is fully compliant with the criteria defined in IVDR Article 5(5) including a robust quality management system, ISO 15189 accreditation, device review and device declaration procedures inclusive of ensuring IVDR Annex I general safety and performance requirements (GSPRs) are met.

Find out how we meet IVDR Article 5 (5) Requirements

The following document outlines in more detail how Almac Diagnostic Services meets all the requirements of IVDR Article 5.

Download article

Interested in Partnering with Almac as a Health Institution?

Get in touch today to start a discussion around your EU Clinical Trial requirements.

Contact Our Regulatory Experts

IVDR – Background

Medical technologies are tightly regulated in the European Union.

Previously, under IVDD guidelines – Roughly only 20% of devices were certified by a notified body with a CE mark on market. Now, under the new IVDR regulation – This number increases dramatically and more than 80% of all new devices will need certification by a notified body to obtain a CE Mark and be placed on market.

Before an IVD (in-Vitro Diagnostic) can be legally placed on the EU market, a manufacturer must comply with the requirements of all applicable EU legislation and affix a CE mark to their device.

IVDR – Impact for Biopharma Companies & Clinical Trials

Recently issued EU guidance on the interface between the Clinical Trial Regulation (CTR) and IVDR places increased responsibility with pharma sponsors for the oversight, safety and performance of tests selected for use within drug clinical trials by the trial sponsors.

This guidance obligates the sponsor of drug clinical trials to obtain a statement of compliance to IVDR’s general safety and performance requirements (GSPR) from manufacturers of IVDs for use within clinical trials.

Additionally for unapproved tests utilised in an interventional manner (e.g. where treatment arm is being determined by the test) or as performance devices where the device is under investigation, the IVD manufacturer will be required to obtain clinical performance study (CPS) regulatory approval for use of their test from each EU Competent Authority in which the clinical trial is active.

Almac IVDR Support for Biopharma Companies

Almac Diagnostic Services can support Biotech and Pharma companies with up-to-date guidance and support for your biomarker programmes around IVDR and compliance with the new regulations for Europe.

Almac is well positioned to meet the requirements of IVDR to provide services that allow the development, validation and delivery of clinical trial assays for analysis of specimens from EU clinical trial sites.
Almac can ensure that pharma clinical trial sponsors meet their obligations under CTR.
Almac can ensure that not only EU requirements are met, but additionally for our Biopharma partners global trials, that all other regulatory requirements are aligned optimally for smooth IVD approval in each region.

Almac IVDR Preparedness

Almac has reviewed the appropriate IVDR Regulation.
Almac has updated our procedures and documents as part of our QMS to ensure compliance, including PMS (Post Marketing Surveys) & reporting, GSPRs (General Safety & Performance Requirements) and Scientific Validity.
Almac has already transitioned some CE Marked assays from IVDD to IVDR to allow use within clinical trials within the transition period by our Biopharma clients.
Almac is currently in the process of submitting Clinical Protocol Study (CPS) applications (on behalf of major Pharma & Biotech partners) for current assays to enable use of data for registrational trial purposes including:
- Spain
- Portugal
- Germany
- Turkey

Almac’s Unique Geographical Location & IVDR Benefits

Northern Ireland is the only part of U.K. to have a land border with the EU. Almac Diagnostic Services, is in the unique global position of being based in Northern Ireland, which, due to the Windsor Agreement, has unfettered access to both the EU and UK Markets.

The UK Government has guaranteed unfettered access for Northern Ireland’s businesses to the rest of the UK internal market. For medical devices, this means that any CE marked device held by a Northern Ireland business is valid for the whole of the UK market provided it falls within the definition of a qualifying “Northern Ireland good”. Therefore, CE marked devices that can be placed on the Northern Ireland market and are qualifying Northern Ireland goods, can also be placed on the UK market and will not need to undergo any further registration in Great Britain.

This places Almac in an extremely advantageous position for assay development and deployment in clinical trials, saving time, costs & additional regulatory hurdles along the approval process for assays approved from our Craigavon laboratory.

Almac Diagnostic Services Blog – ‘Almac Voice’

Read our latest blog on “Potential impact of IVDR on diagnostic testing in Europe – What are the implications for the pharmaceutical industry?”

Written by Joe Clune, CDx commercialisation consultant and Stewart McWilliams, VP of Quality and Regulatory Affairs at Almac Diagnostic Services, the blog covers the following key topics:

Introduction to IVDR
IVDR – What’s New?
Challenges in the implementation of IVDR
Background – Companion Diagnostics
The evolving landscape of approved tests vs LDTs
Will Europe still have LDTs with IVDR?
What does Pharma need to do?

Download

Almac Webinar – Available on demand

In this Almac webinar, hosted by X Talks, the expert speakers focus on their experience with IVDR and describe strategies for solving the specific challenges faced during the IVDR submission process for clinical trial assays being utilised as CDx, allowing global trials to commence and complete in a timely manner.

Download this webinar today where experts will share their experience with EU IVDR and provide insights into solving challenges faced during the EU IVDR submission process.