Services / MDR and IVDR
EU MDR certification and IVDR support for device manufacturers
For medical device and in vitro diagnostic manufacturers who need CE marking under the EU MDR or IVDR: we prepare your documentation and quality system and coordinate the notified body.
From $2,000Consultancy and notified body package
- Accredited by IAB and INTAQS
- Issuing certificates since 2004
- Online or on-site audits worldwide
- Verify any EUROTECH certificate
What the MDR and IVDR package includes
The EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 set the rules for placing medical devices and diagnostics on the EU market. They replaced the earlier directives with stricter requirements on clinical and performance evidence, technical documentation, post-market surveillance, traceability and the role of notified bodies.
Under both regulations, the manufacturer must classify the device, meet the general safety and performance requirements, run a quality management system, prepare technical documentation, carry out a conformity assessment and register in the EU database. For all but the lowest-risk devices, a notified body must assess the quality system, the technical documentation or both.
Our package covers the preparation and coordination work, so your file reaches the notified body complete and consistent.
- Device classification under the MDR rules (classes I, IIa, IIb, III) or IVDR rules (classes A to D)
- Gap analysis of your technical documentation and quality management system
- Support on clinical evaluation or performance evaluation documentation
- Post-market surveillance and vigilance procedures
- UDI, labelling and instructions for use review
- Selection of a designated notified body and coordination of the assessment
Software can be a medical device in its own right under both regulations, and is often classified higher than under the old directives. If your product includes software that analyses data to support diagnosis or treatment decisions, we check its classification early.
Routes by device class
Class I medical devices that are not sterile, have no measuring function and are not reusable surgical instruments can be self-declared by the manufacturer under the MDR. All other classes need a notified body. Under the IVDR, most diagnostics now need a notified body, a big change from the old directive where most were self-declared.
Higher classes bring deeper assessment. Class IIa and IIb devices usually need quality system assessment plus sampling of technical documentation; class III and implantable devices need assessment of each device's technical documentation and, for some, an additional expert panel procedure. IVDR class C and D devices follow similarly strict routes, with class D involving EU reference laboratories.
The EU has extended the transition periods for devices certified under the old directives, subject to conditions such as a signed agreement with a notified body and a quality system in place. The exact deadlines depend on the device class. We check where your devices stand and plan the route and timeline accordingly.
Custom-made devices, systems and procedure packs, and devices without a medical purpose listed in the MDR annex follow their own specific rules. If your product falls into one of these groups, the route is different, and we confirm it at the start.
What decides the price
MDR and IVDR packages with EUROTECH start at $2,000. Notified body fees are not included in our price. They are set by each notified body, depend on the device and are quoted separately by the notified body.
- Device class and conformity assessment route
- Number of devices or device families
- State of your documentation and quality system
- Clinical or performance evidence already available
- Transition from legacy certificates under the old directives
We confirm the scope, our fees and the expected notified body costs in a written quote after a short review of your devices and documents.
Legacy devices moving from the old directives often need less new work than new devices, but evidence gaps can still be significant.
How MDR and IVDR works with us
Step 1
Classification and QMS gap
We classify your devices and review your documentation and quality system against the regulation.
Step 2
Design and risk files
Technical documentation, risk management and clinical or performance evaluation are prepared.
Step 3
Production audit
The notified body assesses your quality system and documentation, with our coordination.
Step 4
Certificate and market access
After the notified body decision you register and place the device on the EU market.
Manufacturers outside the EU
Many of our clients are device makers in the USA, Asia and Africa who want access to the EU market. A manufacturer outside the EU must appoint an EU authorised representative, whose details appear on the labelling and in the EU database. Importers and distributors in the EU also have defined obligations.
Each manufacturer must have at least one person responsible for regulatory compliance with documented expertise; small companies can have this person available through an external arrangement. We help you set up these roles correctly.
If you already hold FDA clearance or ISO 13485 certification, much of your evidence can be reused, but the MDR and IVDR have specific requirements, for example on clinical evaluation and post-market surveillance, that usually need additional work.
Language requirements apply as well. Labelling and instructions for use must be provided in the languages required by each member state where the device is made available, which affects packaging design and launch planning.
What to expect during the project
We start with classification and a gap analysis, then agree a plan with you. Documentation is built or updated to the structure the regulations require: device description, design and manufacturing information, general safety and performance requirements checklist, benefit-risk analysis and risk management, product verification and validation, and clinical or performance evaluation.
In parallel, the quality system is aligned with the regulation, usually on the basis of ISO 13485, adding the MDR or IVDR specific processes. When the file is ready, we support the application to the notified body and help answer its questions during the assessment.
Notified body capacity can be limited, so starting the conversation early is important. We plan around realistic timelines rather than promising dates that depend on the notified body.
Clinical evidence is often the longest part of the work. For many devices, literature and equivalence arguments are no longer enough on their own, and a post-market clinical follow-up plan is expected. We assess what evidence you have and what is still needed, so the plan is realistic.
After CE marking
Under the MDR and IVDR, certification is the start of continuous obligations: post-market surveillance, periodic safety or surveillance reports depending on class, vigilance reporting of serious incidents, updates to clinical or performance evidence and surveillance audits by the notified body, which may include unannounced audits.
Keep your technical documentation alive. Changes to the design, materials, suppliers or intended purpose must be assessed and, where significant, notified to the notified body before they are implemented.
Keep the person responsible for regulatory compliance involved in every significant change, so obligations are not missed when the business moves quickly.
How this service works: EUROTECH is not a notified body. We provide the consultancy and coordinate the conformity assessment with an EU notified body designated for your device type. Certificates under the MDR and IVDR are issued only by notified bodies, and the decision is theirs. Notified body fees are not included in our price.
Questions buyers ask
How much does MDR or IVDR support cost?
Our packages start at $2,000. Device class, number of devices, documentation readiness and evidence set the final price. Notified body fees are not included and are quoted separately.
Is EUROTECH a notified body?
No. Only notified bodies designated under the MDR or IVDR can issue certificates. We prepare your file and coordinate the assessment.
Does my class I device need a notified body?
Not if it is non-sterile, has no measuring function and is not a reusable surgical instrument. Otherwise a notified body is involved for those aspects.
Have the MDR and IVDR deadlines been extended?
The EU extended the transition periods for legacy devices, subject to conditions. Deadlines depend on the device class, and we check them for your devices.
Do we need an EU authorised representative?
Yes, if you are a manufacturer based outside the EU.
Is ISO 13485 enough for the MDR?
ISO 13485 is the usual basis for the quality system, but the MDR and IVDR add specific requirements that must also be met.
Related services
- ISO 13485 certification
From $800
- CE marking
From $800
- FDA registration
From $1,000
Get a quote for MDR and IVDR
Tell us your company, sites and the standard you need. We reply with a written quote and the audit plan.
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