Radio Equipment Directive (2014/53/EU)
There is a new publications in the OJEU of standards harmonised under the Radio Equipment Directive:
* 14th October 2016 2016/C 381/01 4 standards added
This brings the total number of standards harmonised under the RED to 12 (compared to 217 standards harmonised under the R&TTE Directive).
ETSI is still very busy updating standards, but there is a long way to go.
Medical Devices Directive (93/42/EEC)
There is a new publications in the OJEU of standards harmonised under the Medical Devices Directive:
17th November 2017 2017/C 389/03 13 standards added, including
Active Implantable Medical Devices Directive (93/42/EEC)
There is a new publications in the OJEU of standards harmonised under the Active Implantable Medical Devices Directive:
17th November 2017 2017/C 389/02 4 standards added
In Vitro Diagnostic Medical Devices Directive (93/42/EEC)
There is a new publications in the OJEU of standards harmonised under the In Vitro Diagnostic Medical Devices Directive:
17th November 2017 2017/C 389/04 4 standards added
ETSI have released some extremely useful gap analysis documents for a range of popular ETSI standards. Using these documents it’s a simple exercise identifying important changes that could affect your compliance requirements.
NOTE: All the compared versions are available in PDF version 
What is Gap Anlaysis?
Gap Analysis for certification is the process of checking your technical file when the standards its certified to have been updated. Then assessing the changes to evaluate if retesting is required.
Why do i need Gap Analysis?
If a company can identify through a gap analysis that retesting is not required it can save a lot of time and money by not repeating the certification process.
Can a Gap Analysis go in my technical file?
Yes it absolutely should, the document can be used as evidence of due diligence when standards change.
What does a Gap Analysis look like?
Gap analysis is generally a report that identifies the changes and summaries its impact. Gainspeed have carried out lots of gap analysis for its clients, please contact us if you would like us to carry out a gap analysis assessment for you today.
