Emergo wurde von UL (Underwriters Laboratories) akquiriert und wird sein Beratungsangebot zur Qualitätssicherung und zu regulatorischen Angelegenheiten erweitern.
Notified Bodies BSI, TÜV Rheinland, TÜV SÜD, LNE-GMED and DEKRA/KEMA have made public a code of conduct they drafted earlier this year in accordance with Directives 90/385/EEC and 93/42/EEC.
The European Union’s Restriction on Hazardous Substances (RoHS) Directive covering electronic devices will soon also cover medical devices.
The law has been fashioned to improve collection and recycling rates of electronic devices across the EU, as well as to cut down on illegal exporting of electronic waste products from the EU.
In Europe, a response was published to public comments on the proposed recast of Directive 98/79/EC.
As previously reported, the TGA reformed IVD regulations in 2010 to align with GHTF recommendations, adopting a risk-based classification system. Under the new system, many IVDs will be subject to more rigorous controls, including random and mandatory audits. TGA has now published multiple IVD guidance documents.
The TGA has most recently issued guidance outlining several key points regarding IVD application audits (Technical File Review), including:
Comments following European Union regulators’ public consultation on proposed revision to Directive 98/79/EC indicate
The Therapeutic Goods Administration (TGA), Australia’s medical device regulator, has specified which in vitro devices (IVDs) will be required to undergo
The Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were issued on 25 February 2010. The changes will be implemented on 1 July 2010, and serve to amend the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990. The major changes to TGA legislation pertain to the currently largely unregulated in-vitro diagnostic devices (IVDs); the likely implications of which are described below.
IVDs will now be regulated by the TGA effective 1 July 2010. Though the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were issued on 25 February 2010, the changes will be implemented on ...
There are modifications to TGA medical device applications, TGA's public regulatory consultation, and IVD guidance.