• Medical Devices
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Medical Devices and EU 2017/745, exclusive interview

The legislation governing medical devices (MDs) having largely demonstrated its ineffectiveness during the PIP implant scandal, the new 2017/745 regulation reinforces patient safety by introducing clinical evaluation of the MD, post-market surveillance and a unique identification system for better traceability is more transparency. Stéphane ANCEL, Commercial Director at Ackomas, presents Ackomas' approach and its innovative…

ackomas

For ackomas, the 17 Jan 2024

Reading time: 1 min.

  • Medical Devices
  • News

Published in DeviceMed France

Published at the beginning of September, DeviceMed France's latest issue looks at Eudamed compliance, the means to achieve it and the urgent need to implement suitable tools, featuring KOA software, a SaaS solution developed by Ackomas. Happy reading! Download the article

ackomas

For ackomas, the 12 Sep 2023

Reading time: 1 min.

  • Medical Devices

Eudamed registration, creation of the Master UDI-DI

European regulations require a unique identification system for medical devices (UDI) to improve and facilitate traceability. After launching a major consultation process last spring, the European Commission has just approved the creation of a Master UDI-DI for certain so-called "highly individualized" medical devices. The medical devices, such as contact lenses, which were included in the…

ackomas

For ackomas, the 11 Jul 2023

Reading time: 2 min.

  • Medical Devices
  • News

Webinar – Practical questions about Eudamed compliance

The timetable for the implementation of regulations EU 2017/745 and EU 2017/746 continues to unfold, with an important next step: the operational qualification of the EUDAMED database. This step, which makes mandatory the publication of data on Medical Devices and In Vitro Diagnostics, still raises many questions among industry professionals. Ackomas is organizing a webinar…

ackomas

For ackomas, the 06 Jul 2023

Reading time: 2 min.

  • Medical Devices

The European Commission approves the extension of transitional periods for MD

Extension of transitional periods for MD - Further to the implementation of European Regulation (EU) 2017/745 & 746, thousands of medical devices are currently pending certification, a situation which is raising great fears of a widespread shortage in Europe. In particular, the lack of notified bodies, the recent pandemic, and the geopolitical context of the…

ackomas

For ackomas, the 22 Feb 2023

Reading time: 2 min.

  • Medical Devices

MD, towards an extension of the transitional period?

Since 2017, the regulatory requirements for all medical devices have been strengthened to ensure optimal end-user and patient safety, as well as the proper functioning of the internal market for DMs. Now, conformity assessment of DMs is more complex to ensure the quality and performance of devices. At the start of this year, the European…

ackomas

For ackomas, the 12 Jan 2023

Reading time: 2 min.

  • Medical Devices

MD compliance and certification, the key role of QMS

Manufacturers are held directly responsible to competent authorities for their medical devices. Regardless of the device’s class, a Quality Management System is mandatory for proving product quality control. While ISO 13485 is not directly required in order to obtain the CE mark,[1] it remains a recognised reference that demonstrates the manufacturer’s compliance with the laws and…

ackomas

For ackomas, the 13 Dec 2022

Reading time: 3 min.

  • Medical Devices

UDI for MDs – identifying the right manufacturer to ensure regulatory compliance

Thousands of companies operate in the field of medical devices (MDs) throughout Europe, and all of them are affected by the implementation of Regulation (EU) 2017/745. This new regulation has considerably increased the level of requirements for MDs, bringing them in line with those of the pharmaceutical industry. It also introduces improved procedures for clinical…

ackomas

For ackomas, the 11 Nov 2022

Reading time: 5 min.

  • Medical Devices

The European Medical Device Nomenclature

The European Medical Device Nomenclature is an essential document for all MD manufacturers who wish to place their products on the market. The first, essential step is to define the class assigned to the product. This is indeed of great importance. This step will define the regulatory requirements which will need to be met to…

ackomas

For ackomas, the 05 Oct 2022

Reading time: 2 min.

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