{{ phone }} {{ location }}

Emergo by UL logo

         

IVD

UL übernimmt Emergo

Emergo wurde von UL (Underwriters Laboratories) akquiriert und wird sein Beratungsangebot zur Qualitätssicherung und zu regulatorischen Angelegenheiten erweitern.

Recast of EU’s Hazardous Material Regulations to Impact Medical Devices

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.

Australia TGA Clarification on IVD Audits

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:

Australian TGA Updates IVD Regulations

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.