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Healthcare

Healthcare is one of Obelis’ main points of expertise, managing both the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR) to help you place and represent your devices on the EU market.

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Product Categories

Explore the details on your product category within the healthcare industry. Contact us for inquiries.

Healthcare

Medical Devices

Healthcare

In-Vitro Diagnostics

Healthcare

Aesthetic Devices

News from within the industry

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Products falling under the General Product Safety Directive (GPSD): compliance process with the new Regulation from 2024

On 23 May 2023 the Official Journal of the EU published a new law, the General Product Safety Regulation (GPSR). From 13 December 2024, manufacturers will have to comply with the new GPSR.

Webinar: Steps to enter the Australian market for Medical Devices

Manufacturers! Interested in the European Commission proposal for legacy devices? Our consultant will be offering an interpretation of the European Commission proposal for legacy devices regarding the following date: March 20, 2023

What is CE Marking?

A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.

Healthcare

Product Categories

Medical Devices

In-Vitro Diagnostics

Aesthetic Devices

News from within the industry

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