New EU regulation shifts in-vitro device classification from list-based to risk-based, allowing for greater innovation and scope for manufacturers in Europe.
Medical devices and healthcare
EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices
EU vote confirms cranberry products are not medical devices. This is the first borderline product ruling adopted based on MDD 13(1)(d).
Transition of Notified Body from NB0434 and NB0470 to DNV GL Nemko Presafe NB2460
DNV GL Nemko Presafe NB2460 began operating in May 2017, a merger of former Norwegian notified bodies DNV GL Business Assurance Norway and Nemko AS NB 0470.
New limits for BPA in toys
New EU Commission Directive 2017/898 is set to enforce higher restrictions on Bisphenol A (BPA) in toys in the interest of consumer safety in Europe.
Products without medical purpose within the scope of MDR
The new EU Medical Devices Regulation 2017/745 (MDR) officially entered into force on 25th May 2017 amending the Directive 93/42/EEC and will be fully applicable after a transition period of three years (2020). One of the most relevant changes introduced by the new Regulation lies in the extension of its scope, now including certain “products without an intended medical purpose”.
New countries admitted to the Hague Conference
Dominican Republic, Colombia, Kazakhstan and Lebanon have been added to the Hague Conference on Private International law taking place in June 2017.
New Responsibilities of EAR under the new MDR
Learn more about the new responsibilities set in force in May 2017 for European Authorized Representatives under EU medical device regulation 217/745.
The new EU UDI codes for Medical Devices
The Unique Device Identifier system and codes have been introduced to Europe under the new medical device and IVD regulations. Find out more with Obelis.
France’s new adverse reporting portal for cosmetics
Discover what's an adverse health related event, and the new portal for cosmetics.
The new South African Health Products Regulatory Authority (SAHPRA)
The South African government has formed an independent, state-owned agency, SAPHRA, to oversee medical device and pharmaceutical regulatory systems.