In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746

IVDR stands for ‘In Vitro Diagnostic Regulation’. This is a regulation created by the European Commission that comes into effect 26^th May 2022 and sets out requirements for in vitro diagnostic (IVD) medical devices. Manufacturers need to comply with the regulation in order to apply a ‘CE’ mark and sell IVD medical devices into the EU after May 2022.

IVDR replaces the In Vitro Diagnostics Directive (IVDD) which our IVD products currently comply to for CE marking.

A CE mark is required for certain products to be sold within the EU. It is mandatory for products which are covered by the scope of specific European directives or regulations requiring the CE mark, e.g. toys, electronics, personal protection materials, medical devices or in vitro diagnostics. In simple terms, for Thermo Fisher Scientific Microbiology it means that it is required for IVD products intended for a clinical application.

The letters ‘CE’ will appear on the product label and Instructions for Use (IFU) and indicate that;

• The manufacturer has checked that these products meet EU safety, health or environmental requirements
• The product is compliant with EU legislation
• The product has free movement within the European market

By placing the CE mark on a product, a manufacturer is declaring their sole responsibility and conformity with all the legal requirements to achieve CE marking. The manufacturer is thus ensuring validity for that product to be sold throughout the European free market.

The IVDR implements a number of important changes to the current regulation, among which:

• More stringent requirements for documentation e.g. post-market surveillance, technical documentation
• New classification: Class A (low risk) – Class D (highest risk). Class B, C, and D need approval by a Notified Body. Class A products continue to be self-certified.
• More stringent requirements for clinical evidence
• UDI: unique device identification number for every device
• EUDAMED: Europe-wide database of increased transparency and traceability
• Increased surveillance by Notified Body

Thermo Fisher takes IVDR compliance very seriously, and there is a dedicated project team working to upgrade our documentation and processes at sites that manufacture CE marked IVD products. We are working on the agreed priority lists of clinical products in order to meet the IVDR deadlines.

All IVDs manufactured with a CE mark are affected by IVDR.

In the existing clinical microbiology portfolio, most products are in scope and you will see no change. If any products will have a change in status or will be removed as part of IVDR, alternative products will be identified where possible. The IVDR team is working to implement any changes and will communicate to affected customers in due course. We will provide notice to ensure you have enough time to validate any changes.

The majority of Thermo Scientific Microbiology IVD products will remain self-classified (Class A) and do not to be reviewed by a Notified Body. The remaining IVD products will be mostly Class B with some Class C. These Class B/C products require conformity assessment by a Notified Body that is designated in accordance with the IVDR.

Yes, we have successfully completed our application with an IVDR-designated Notified Body. We are in close contact with them to advance through the process to obtain our first IVDR-compliant CE marks. 

There is an active, dedicated project team working towards the applicable IVDR deadlines. We have written and submitted many technical files to our Notified Body and are advancing through the process to obtain IVDR certificates.

The Declaration of Conformity is the manufacturer’s formal declaration that the devices listed on the document are in conformance with the applicable legislation and needs to be completed for all CE marked products.

A declaration of conformity is available for each Thermo Fisher Scientific Microbiology legal manufacturer of CE marked IVD products sold into the EU, including Oxoid Ltd, Oxoid GmbH, Trek Diagnostics, Remel Europe and Remel Inc. If a Declaration of Conformity is required, please contact your local Technical Support.

Yes, as part of our transition activity, labels and IFUs are being updated to include all required information to comply with IVDR. These changes will be implemented once we have received the IVDR certificate from our Notified Body, or when we are able to self-declare compliance for Class A products. If a copy of the label is required, please contact your local Technical Support.

As part of our transition activity, labels and IFUs are being updated to include all required information to comply with IVDR. These changes will be implemented once we have received the IVDR certificate from our Notified Body, or when we are able to self-declare compliance for Class A’s. IFUs will be available on the product webpages on the Thermo Fisher website.

IFUs for products CE marked under IVDR will be translated into languages to cover the countries where the product is sold.

We have two products currently certified under IVDD; IMAGEN™ Chlamydia kit and its control slide. These devices will be transitioned alongside our other IVD products.

We are already creating plans to gather the required data for EUDAMED upload when modules become available. We will work in accordance with EU deadlines on EUDAMED uploads. 

IVDR-compliant post market surveillance procedures are already in place and upgrades to current reports will begin in 2021. All post market surveillance plans have been updated. The vigilance procedure is being updated to ensure that we will work in accordance with IVDR requirements.

The UKCA (UK Conformity Assessed) marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods which previously required the CE marking, known as ‘new approach’ goods.

We plan to comply with UKCA requirements for IVDs in parallel with IVDR implementation, therefore UKCA marking will appear on our IVD products from early 2022.