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Medical Devices
12/14/2020

Non-compliant medical devices: what are the risks?

Learn about the risks of non-compliance with the new medical devices regulation in Europe, including financial losses, damage to brand image, and sanctions by Member States. Understand evolving obligations and how to ensure compliance to avoid these risks.
Medical Devices
12/7/2020

Regulation 2017/745 on MDs: what are the major changes?

The new Medical Device Regulation expands the scope to cover non-medical devices and changes device classifications. Notified Bodies are now under stricter control, leading to longer time to market. Economic operators have specific roles and obligations. Stricter rules for clinical evaluation and post-marketing monitoring. A unique identification system and EUDAMED database enhance traceability. Regulation 2017/745 aims to improve transparency and safety of medical devices in Europe.
Medical Devices
8/27/2020

5 questions on... the new European medical devices regulation

Although its application has been postponed for one year, the new medical devices regulation implies many changes for companies. It is important to prepare for them now. EcoMundo reveals the answers to the 5 most common questions on the subject.
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Authors

Christian Freneuil
Fang Zhou
Jeanne Pontisso

Ecomundo

EcoMundo is a specialist in chemical substances, their action on human health and the environment as well as the international regulations that govern chemical risk (REACH Regulation, CLP, Cosmetics and OTCs, Biocides, Food, etc.).

Via expert services and software, we support the launch of industrial products, enabling companies to manage risks relating to chemical substances. EcoMundo’s strength lies in the combination of three
complementary areas of expertise:

  • Chemicals & Toxicology
  • Regulations
  • Software

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