NB won't issue CE Certificate or return phone calls

[Bunny]

We had a NB audit in Dec 2017 for a Class I medical device. A major was issued and subsequently closed in March 2018. Invoices were paid. Yet still the CE certificate remains to be issued. No one from Semko (Intertek) is providing answers. I suspect that Semko may have lost right to issue certificate. How can I investigate? Can I file complaint? My company is on verge of having current CE certificate pulled from UK and still Semko ignores requests for status update.

 

[Sidney Vianna]

How can I investigate?

The list of suspended/revoked/withdrawn notifications for the Medical Device Directive can be accessed >>HERE<<

Can I file complaint? My company is on verge of having current CE certificate pulled from UK and still Semko ignores requests for status update.

Is your legal department involved? Depending on the Competent Authority for your NB, you can escalate the issue to them. Find contact information @ NBOG Contact Points

Good luck

 

[Bunny]

I am going to ask them to get involved after today. I still want to file a complaint. Thanks.

 

[Lorenzo]

Does your notified body have the number 0359? Then the accreditation was really withdrawn.