IVD
Bringing an IVD to the EU market means meeting Regulation (EU) 2017/746 (IVDR) - a major step up from the old directive, with a risk-based Class A to D system, far greater Notified Body involvement, and phased transition deadlines running to 2029.
At Taylored Consultancy Ltd, we make IVD compliance clear and stress-free. From classification and performance evaluation to your technical documentation and CE marking, we help you meet IVDR requirements and hit the transition timelines without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your diagnostics compliant, reliable, and ready for market.
We determine the correct class (A, B, C or D) under IVDR, which drives your conformity assessment route and Notified Body involvement.
With phased deadlines through 2027-2029 (conditional on having an IVDR-compliant QMS in place), we help you plan and stay on track.
We help you compile scientific validity, analytical and clinical performance evidence, and your Performance Evaluation Report.
We build your risk management file to the recognised standard.
We help you build IVDR-compliant technical documentation that stands up to Notified Body scrutiny.
We review your labelling and instructions for use (ISO 18113), including UDI and EUDAMED requirements.
Non-EU manufacturers need an EU Authorised Representative and EUDAMED registration. We act as your EC REP and handle registration.
We help you implement an IVDR-ready QMS to ISO 13485 - required to benefit from the transition timelines.
We help you evidence usability and human-factors work to show your IVD is safe to use.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
ISO 13485 - Medical devices QMS
ISO 14971 - Risk management for medical devices
ISO 15189 - Medical laboratories quality and competence
ISO 15197 - Blood glucose monitoring systems
ISO 18113 - IVD labelling and instructions for use
ISO 23640 - Stability evaluation of IVD reagents
CLSI guidelines - Laboratory method validation
IEC 61326 - EMC requirements for laboratory equipment
ISO 9001 - General quality management
IEC 62366 - Usability Engineering
Under the old IVDD, most IVDs could self-certify. Under IVDR, that's reversed, and the vast majority now need Notified Body involvement because classification is risk-based (Class A to D) rather than largely self-assessed. If your device previously self-certified, don't assume it still can; reclassification is usually the first thing we check for clients moving across.
It depends on the risk your IVD poses to patients and public health: Class A covers general lab equipment and lowest-risk products, through to Class D for tests like blood-borne infectious disease screening, the highest-risk category. Classification drives everything else, including the evidence you need, whether a Notified Body is involved, and your realistic timeline, so it's the right place to start.
EUDAMED is the EU's central database for medical devices and IVDs, and if you're placing a device on the EU market under IVDR, you'll need to register your device, economic operator, and UDI information on it. Its modules are rolling out in phases, so requirements are still evolving. We keep clients' EUDAMED and labelling obligations aligned as each module goes live.
Yes. IVDR set phased transition deadlines running through to 2027-2029 depending on your device's risk class, giving manufacturers longer runways where certification or a declaration of conformity was already in place before the relevant cut-off. The exact date that applies to you depends on your class and certification history, so check it against your specific device rather than assuming.
If you manufacture outside the EU and want to place an IVD on the EU market, yes, you need an EU Authorised Representative (EC REP) to act on your behalf and hold your technical documentation available to authorities. We provide EC REP services alongside EUDAMED registration, giving non-EU manufacturers a single point of contact for EU compliance.
IVDR expects a much deeper performance evaluation than IVDD did. Scientific validity, analytical performance, and clinical performance all need to be demonstrated and documented, not just asserted. For higher-class devices this evidence gets far more scrutiny from Notified Bodies, so building it properly from the outset saves costly rework later.
It's generally a smooth administrative process rather than a regulatory hurdle. Your new EU Authorised Representative takes on your existing technical documentation and EUDAMED registration, confirms your device details are current, and updates the Authorised Representative information in the portal and on your labelling. We manage that handover directly with your previous provider, so your device stays compliant and on sale throughout the switch.
An EU Authorised Representative carries legal accountability for an IVD across the EU market, covering EUDAMED registration, holding technical documentation available for inspection, handling vigilance reporting, and acting as the contact point for national competent authorities if a device is ever questioned. It's a standing obligation for as long as the device is on sale, not something that ends once the initial registration is filed.
Yes, in most cases. EU IVDR requires labelling and instructions for use to be provided in the official language, or languages, of the member state where the device is being made available, so a technical file built for one EU country typically needs local-language versions before it can be sold elsewhere. Your underlying performance evidence and technical documentation stay the same; it's the label and IFU translations that need handling market by market.
Still have questions? Contact us and we'll be happy to help.
