Question 1

What is regulatory support for medical devices?

Accepted Answer

Regulatory support for medical devices covers all services helping manufacturers navigate MDR 2017/745 and IVDR 2017/746 requirements: technical documentation, clinical evaluation, notified body selection, CE marking preparation, and market access strategy for Europe and Switzerland. Normiq automates these processes with AI, reducing certification time by 40% while ensuring full regulatory compliance.

Question 2

How does Normiq help find a notified body for my medical device?

Accepted Answer

Normiq analyses your medical device classification (Class I, IIa, IIb, III or IVD), your target market and technical characteristics to recommend the most suitable notified bodies. We compare timelines, costs, specialisations and availability of notified bodies designated under MDR 2017/745 and IVDR 2017/746.

Question 3

What is a notified body and why do I need one for CE marking?

Accepted Answer

A notified body is a conformity assessment body designated by an EU member state to evaluate medical devices before they are placed on the market. For Class IIa, IIb, III devices (MDR) and Class B, C, D (IVDR), involvement of a notified body is mandatory to obtain CE marking. Normiq guides you through the selection process and dossier preparation.

Question 4

How can I accelerate market access for my medical device in Europe?

Accepted Answer

Normiq accelerates your MDR market entry by automating your certification roadmap creation, proactively detecting non-conformities in your technical documentation, and guiding you step by step towards CE marking. Our AI analyses your file and identifies gaps before the notified body finds them, reducing back-and-forth and delays.

Question 5

Is Normiq suitable for all types of medical devices?

Accepted Answer

Yes, Normiq supports all medical devices (Classes I, IIa, IIb, III) under MDR 2017/745, all in vitro diagnostics (Classes A, B, C, D) under IVDR 2017/746, as well as pharmaceutical products. Our platform automatically adapts to the specific regulatory requirements of your product category and target market.

Question 6

Does Normiq replace a notified body or regulatory consultant?

Accepted Answer

No, Normiq is a regulatory compliance support tool that complements the work of your consultants and notified bodies. The platform optimally prepares you upfront: certification roadmap, document management, non-conformity detection. This significantly reduces the time and costs of MDR/IVDR certification.

Question 7

How does Normiq handle Swissmedic compliance for the Swiss market?

Accepted Answer

Normiq integrates Swiss market-specific requirements: Swissmedic notification for Class IIb and III devices, ODim requirements (Medical Devices Ordinance), authorised representative in Switzerland, and reimbursement pathways (LiMA, SwissDRG). The platform guides you on the key differences between EU and CH regulatory pathways.

Question 8

Is my data secure?

Accepted Answer

Absolutely. All your data is encrypted in transit (TLS 1.3) and at rest (AES-256). Our database is hosted in Switzerland and we are GDPR compliant. Your technical documents and product information are never shared with third parties.

Question 9

Does Normiq only cover Europe and Switzerland?

Accepted Answer

Currently, Normiq focuses on EU (MDR 2017/745, IVDR 2017/746) and Swiss (ODim, LPTh, Swissmedic) regulations. We are actively working on expanding to the USA (FDA 510(k), PMA), Canada (Health Canada) and the UK (UKCA/MHRA). These markets will be available during 2026.

Regulatory support for your medical devices

Less time on regulations, more time on the market

Automatically generated roadmap

The right market, at the right time

Time-to-Market cut in half

Your technical file, written by AI

Reimbursement: unlock new revenue streams

Estimate your market before investing

Anticipate regulatory blockers

Everything in one place

Identify the markets most accessible and most impactful

Allemagne

France

Suisse

Italie

Transparent and simple pricing

Starter

Scale

Enterprise

Frequently asked questions