Nemko AS & DQS - Concern over notification as a Medical Device NB

S

Sintolt

#1
Does anyone know whether Nemko has lost ist accreditation for medical devices? There is a "warning symbol" on the comission website:

"The Commission has not received assurance of the continuing competence of this NB concerning its tasks under 93/42/EEC Medical devices"

What does that mean?
 
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SteveK

Trusted Information Resource
#2
Re: Nemko AS - Concern over notification as a Medical Device NB

AMTAC (Intertek) had a similar issue last year (same symbol appeared); the result in our case was that they indicated that there was a high risk that they could no longer support our certification. This was after they were audited by the MHRA and other CAs – the result of which would appear to have questioned their competence as a NB (the symbol is no longer there though and they still have there NB accreditation with the MHRA). Thus we had to change NB but had a reasonable timescale to do so, unlike OBLs who had their certifications pulled with immediate effect. Could be a similar issue with NEMKO, but that is pure speculation. Could be something or nothing – perhaps they did not tick the right box at the right time! You do see these warning symbols come and go with other Directives as well.

Steve
 

SteveK

Trusted Information Resource
#3
Just an update, NEMKO AS (NB 0470) appears to have had its Medical Device certification withdrawn as of 18th April and they are no longer listed as a member of Team NB.

Steve
 

SteveK

Trusted Information Resource
#4
From the NANDO site another NB appears to have its CE certification expired/withdrawn - as of today! IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. (0051) seems to be quite a large organisation. With the MDR coming into effect as of 26th May, is this indicative of the demise of a dearth of NBs?

Steve
 

SteveK

Trusted Information Resource
#5
It is very strange that the NB IMQ (0051); which had its certification withdrawn/expired, has now had its certification returned a few days after this date (reported last update). It must concern its customers; mind you as has been pointed out before, the NANDO site can be a little slow on updates.

Steve
 

Edward Reesor

Trusted Information Resource
#6
Nemko AS *(NB 0470) was involved in a 2012 merger with DNV GL- Business Assurance (NB 0434) and recently decided to retire both numbers to become one entity, DNV GL Nemko Presafe AS (NB 2460).

Both former NB have ceased to exist under separate entities as of May 18, 2017 (DNV GL) and April 18, 2017 (Nemko AS).
 
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