ZHH MedTech

Medical devices · European market

MedTech in Europe

Regulation, devices, companies and tenders — one reference point for professionals working under MDR and IVDR.

Notified body capacity improves, but class III queues persistPolicy
PolicyFeatured

Notified body capacity improves, but class III queues persist

Average MDR certification timelines shortened in 2026, yet combination products and software-heavy devices still wait longest for conformity assessment.

21 Oct 20264.8kRegulatory Desk

Most read

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1AI triage shifts from detection to worklist prioritisation19 Oct 20267.2k2Distribution consolidation reshapes access to smaller hospital accounts23 Oct 20266.4k3PSUR quality is becoming the weak point in post-market files19 Sep 20265.1k4Notified body capacity improves, but class III queues persist21 Oct 20264.8k5Mid-market surgical robotics pushes into regional hospitals30 Sep 20264.6k

14

Devices

8

Companies

11

Legal texts

Browse by category

Imaging, diagnostics, consumables, surgical, rehabilitation, dental and software

All devices
Medical Imaging2 devicesIVD & Diagnostics2 devicesMedical Consumables2 devicesSurgical & Emergency2 devicesRehabilitation & Physio2 devicesDental Equipment2 devicesMedical Software & IT2 devices

Latest news

Policy, market developments and technology

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Policy

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Notified body capacity improves, but class III queues persist21 Oct 20264.8kIVDR transition for class D assays reaches its final stage16 Oct 20263.2kWhere the AI Act ends and the MDR begins for clinical software9 Oct 20262.7k

Industry

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Distribution consolidation reshapes access to smaller hospital accounts23 Oct 20266.4kFramework agreements tighten the terms of hospital supply14 Oct 20264.0kComponent supply stabilises, but dual sourcing remains the norm2 Oct 20262.5k

Technology

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AI triage shifts from detection to worklist prioritisation19 Oct 20267.2kPoint-of-care molecular testing gains ground outside the laboratory11 Oct 20262.8kMid-market surgical robotics pushes into regional hospitals30 Sep 20264.6k

Selected devices

Intended use and key specifications by risk class

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DeltaDent Imaging Bridge
Class I

DeltaDent Imaging Bridge

Delta Dentaltechnik Sp. z o.o.

CE 2195 · MDR (sample)

PhysioNord Balance Platform BP-1
Class I

PhysioNord Balance Platform BP-1

PhysioNord AB

CE 2409 · MDR (sample)

DeltaDent Air Turbine Handpiece TD-6
Class I

DeltaDent Air Turbine Handpiece TD-6

Delta Dentaltechnik Sp. z o.o.

CE 2195 · MDR (sample)

Medaillon Closed Suction Catheter System
Class IIa

Medaillon Closed Suction Catheter System

Medaillon Santé SAS

CE 0459 · MDR (sample)

Company directory

Manufacturers and distributors, by country and qualification

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Nordklinik Medizintechnik GmbH
N

Nordklinik Medizintechnik GmbH

Germany · est. 1998

Designs and builds radiographic systems, mobile fluoroscopy units and reading workstations at two sites in northern Germany. The portfolio is sold mainly through national distributors, with direct service coverage in the DACH region and the Benelux.

ManufacturerISO 13485
Medaillon Santé SAS
M

Medaillon Santé SAS

France · est. 1994

Produces single-use theatre consumables and dental treatment furniture. Sterile barrier packaging is validated in house, and the company operates a shared sterilisation contract for its European customers.

ManufacturerISO 13485
Adria Diagnostica S.p.A.
A

Adria Diagnostica S.p.A.

Italy · est. 2006

Immunoassay and clinical chemistry supplier with an instrument platform and a reagent menu focused on cardiac and infectious disease markers. Manufacturing and reagent filling are carried out in a single facility near Milan.

ManufacturerISO 13485

Tenders & events

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TenderRheintal Klinikum — digital radiography replacement, two sitesRheintal Klinikum gGmbH · GermanyTenderGroupe Hospitalier Loire-Val — immunoassay analysers and reagentsGroupe Hospitalier Loire-Val · FranceTrade fairEuroMed Device Forum 2027Meridian Exhibitions BV · Belgium

Regulation quick view

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Artificial Intelligence ActRegulationEuropean CommissionIn force 1 Aug 2024Transitional provisions for legacy devicesRegulationEuropean CommissionIn force 20 Mar 2023Electronic instructions for use for medical devicesImplementing ruleEuropean CommissionIn force 26 May 2022

About this portal

ZHH MedTech Portal brings together publicly available information on the European medical device market. This is a demonstration build: certificate numbers, company qualifications and tender notices are sample content and must not be relied on for regulatory, procurement or clinical decisions.

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