EU Directives & Regulations
MDR & IVDR Certification Services for medical devices
As part of IMQ Group, IMQ Gulf supports manufacturers in accessing the European market through conformity assessment, testing and certification services for key EU regulations and directives, with a strong focus on MDR and IVDR.
MDR and IVDR Certification Services for Medical and IVD Devices, Backed by Notified Body Status Recognised Across the European Commission’s NANDO System.
IVDR — Regulation (EU) 2017/746
Regulation (EU) 2017/746 (IVDR) governs in vitro diagnostic medical devices in the EU, having replaced Directive 98/79/EC and become fully applicable from May 2022. It sets out the rules for placing devices on the market and classifies them into four risk-based categories — A, B, C and D — with classification carried out by the manufacturer under Annex VIII.
Before market entry, manufacturers must complete a conformity assessment following the procedures in Annexes IX to XI. For devices in classes A sterile, B, C and D, this assessment must involve an accredited Notified Body chosen by the manufacturer. IMQ S.p.A. has been an accredited Notified Body for IVDR since April 2025, as confirmed by its listing in the European Commission’s NANDO system. The full scope of devices IMQ S.p.A. is authorized to assess is published on NANDO, and IMQ S.p.A. also provides a dedicated regulation document and a downloadable guideline for preparing technical documentation. Companies can request further details or a custom quote directly from IMQ S.p.A..
Before market entry, manufacturers must complete a conformity assessment following the procedures in Annexes IX to XI. For devices in classes A sterile, B, C and D, this assessment must involve an accredited Notified Body chosen by the manufacturer. IMQ S.p.A. has been an accredited Notified Body for IVDR since April 2025, as confirmed by its listing in the European Commission’s NANDO system. The full scope of devices IMQ S.p.A. is authorized to assess is published on NANDO, and IMQ S.p.A. also provides a dedicated regulation document and a downloadable guideline for preparing technical documentation. Companies can request further details or a custom quote directly from IMQ S.p.A..
Key facts
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Regulation(EU) 2017/746 (IVDR)
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ReplacesDirective 98/79/EC
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Applicable sinceMay 2022
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Risk classesA, B, C, D (Annex VIII)
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Conformity assessmentAnnexes IX–XI
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Notified Body forclass A sterile, B, C, D
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IMQ S.p.A. Notified Bodysince April 2025 (NANDO)
Key facts
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Regulation(EU) 2017/745 (MDR)
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ReplacesAIMDD & MDD
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Applicable since26 May 2021
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Also coversAnnex XVI non-medical products
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ClassesI, IIa, IIb, III (Annex VIII)
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Conformity assessmentAnnexes IX–XI
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IMQ S.p.A. Notified Bodysince July 2019 (NANDO)
MDR — Regulation (EU) 2017/745
Regulation (EU) 2017/745 (MDR) governs medical devices in the EU, replacing the earlier AIMDD and MDD directives and applying since 26 May 2021. It covers medical devices for human use and their accessories, as well as certain non-medical products listed in Annex XVI. Devices are classified by the manufacturer into classes I, IIA, IIB and III based on intended use and risk, following Annex VIII.
Manufacturers must then carry out a conformity assessment under the procedures set out in Annexes IX to XI, which vary depending on whether the focus is on technical documentation, quality management systems, or product-by-product verification. For higher-risk classes — including sterile, measuring-function and reusable surgical instrument devices, plus IIa, IIb and III — a Notified Body must be involved. IMQ S.p.A. has held MDR Notified Body status since July 2019, with its scope of accredited devices published in the European Commission’s NANDO system. IMQ S.p.A. also offers downloadable guidelines on technical documentation and Article 61(10) justification, plus custom quotes on request.
Manufacturers must then carry out a conformity assessment under the procedures set out in Annexes IX to XI, which vary depending on whether the focus is on technical documentation, quality management systems, or product-by-product verification. For higher-risk classes — including sterile, measuring-function and reusable surgical instrument devices, plus IIa, IIb and III — a Notified Body must be involved. IMQ S.p.A. has held MDR Notified Body status since July 2019, with its scope of accredited devices published in the European Commission’s NANDO system. IMQ S.p.A. also offers downloadable guidelines on technical documentation and Article 61(10) justification, plus custom quotes on request.
How it works
Your path to CE marking
1
Classification
The manufacturer classifies the device under Annex VIII.
2
Technical documentation
Prepare the technical documentation and QMS evidence.
3
Notified Body assessment
The manufacturer classifies the device under Annex VIII.
4
CE marking
Certificate issued; the device can be placed on the market.