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.
News
The Court of Justice Rules: Contact Lenses Do Not Fall Under the Cosmetics Regulation
European Court of Justice rule that contact lenses do not fall under the scope of new cosmetics regulation 1223/2009.
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MHRA issues a Draft Guidance on the Re-Manufacturing of Single-Use Devices
On July 20th 2015, the Medicines & Healthcare Products Regulatory Agency issued draft guidance on the re-manufacturing of single-use devices on the UK market.
European Court of Justice to Clarify Liability for Medical Device
The European Court of Justice, by request of Germany's Federal Supreme Court, will clarify the liability of notified bodies in relation to medical devices.
Final opinion on the Safety of Medical Devices containing DEHP (phthalate)
Scientific Committee on Emerging and Newly Identified Health Risks publish final opinion on safety of medical devices containing DEHP (phthalate).
EC Proposes to Restrict the use of Methylisothiazolinone (MI): Public Consultation now Open.
Public consultation has opened on the European Commission's proposal to restrict the use of methylisothiazolinone (MI) in cosmetic products.
Revised animal tissue standard could be available by the end of 2015
A revised standard on medical devices utilizing animal tissue could be available by the end of 2015 with new EU regulation 722/2012.
IMDRF proposes QMS Principles for Software as a Medical Device
The new International Medical Device Regulators Forum guidance provides direction on utilizing quality management systems for software as a medical device.
SCCS Opinion on 2,5,6-Triamino-4-pyrimidinol sulfate (Colipa No. A143) and HC Yellow No. 17 (B121)
Learn more about the SCCS' opinion on 2,5,6-Triamino-4-pyrimidinol sulfate (Colipa No. A143) and HC Yellow No. 17 (B121) and how it may affect your products.