The new May Gainspeed newsletter is here. Its a friendly complimentary newsletter on everything compliance.
Some of this months features are.
Headlines
Just a reminder! – the European Commission published a “new” version of “The ‘Blue Guide‘ on the implementation of EU product rules 2014″, (the so called “Blue Book“), in July this year
The new ‘Blue Guide’ builds on the on the content of the Guide to the implementation of directives based on the New Approach and the Global Approach (the “Blue Guide”) published back in 2000, but reflects the modernisation brought to the legal framework in the past decade.
This is not an update as such, as there has been no change to the content – the only difference is in the formatting
Updated guide from the NMRO available on line
The aim of the National Measurement and Regulation Office (NMRO) is to simplify technical regulation for the benefit of British business.
Key changes are:
• the inclusion of the new banned substances (DEHP, BBP, DBP & DIBP),
• the updating of web references
• A new Appendix 3 Legislative references
Take care, there are some errors
Appendix 2 “Exemptions: other applications”
The exemptions for “Lead” and “Cadmium” are incorrectly identified as “Mercury exemptions” in the table on pages 27 through 32.
ISO/FDIS 13485 Medical devices — Quality management systems — Requirements for regulatory purposes Final draft of ISO 13485:2015 has been circulated and is available from BSI:
ISO 13485:2015 is due to be published early 2016.
The new ISO 13485 is applicable across the whole supply chain and seeks to address the entire life cycle of a medical device.
Some of the key changes include:
* Harmonization of regulatory requirements
* Inclusion of risk management throughout the QMS
* Additional clarity with regard to validation, verification, and design activities
* Strengthening of supplier control processes
* Increased focus regarding feedback mechanisms
* Software for QMS, manufacturing and the medical device
Additional information available from BSI:
* Download the BSI white paper on ISO 13485 – The proposed changes and what they mean for you
* Learn more about the ISO 13485 revision
Headlines
Standards Watch
European standards being withdrawn
EU Directives changing
Lists of European Harmonised Standards
Breaking News
Guidance on the new LVD
REACH – Guidance on requirements on substances in articles
A Reminder
“New” version of the CE Marking “Blue Book”
Compliance Calendar
