Understanding the definition of a medical device as outlined by European Medical Device Directive 93/42/EEC. Talk to Obelis for more EU compliance information.
Medical devices and healthcare
Common Approach on the Medical Devices Legislative Package
EU ministers agree to common approach to new medical device and in-vitro diagnostic device regulations, making a major step forward in ratification.
Obelis Launches a Bulgarian National Registration Service
Obelis launches new registration and EAR service for non-EU manufacturers seeking to introduce medical and in-vitro diagnostic devices on the Bulgarian market.
New Harmonized Standards on R&TTE
EU publishes new harmonized standards for Radio and Telecommunication Terminal Equipment in Europe. Talk to Obelis to find out how they may affect your product.
OEM Manufacturers – Obtain your own CE Marking!
Obelis can help Original Equipment Manufacturers and Original Brand Labellers obtain CE marking for their products. We can help you get yours today!
ISO 9001:2015 – A New Approach!
ISO 9001:2015 aims to increase quality and risk management standards globally. Manufacturers will have three years to update current compliance certification.
Obelis Launches the Croatian National Registration Service
Obelis launches new registration and EAR service for non-EU manufacturers seeking to introduce medical and in-vitro diagnostic devices on the Croatian market.
New List of MDD Harmonized Standards Published by the European Commission
Talk to Obelis for more information on the new list of medical device harmonized standards published by the European Commission under Directive 93/42/EEC.
French Court of Appeal clears Notified Body Liability in PIP breast implant case
Aix-en-Provence Court of Appeal in France clear Notified Body TÜV Rheinland of liability in PIP breast implant scandal case.
MHRA issues a Draft Guidance on the Re-Manufacturing of Single-Use Devices
On July 20th 2015, the Medicines & Healthcare Products Regulatory Agency issued draft guidance on the re-manufacturing of single-use devices on the UK market.