This is REALLY strange and I fully agree with Kevin's feedback. I work as a lead auditor for a NB on a freelance basis and I have never seen someting like that.
When a NB loses its recognition, there is normally a certain period until the certificates become invalid. We had a case here in Switzerland where the companies where informed that a NB will cease its activities as NB with a 6 months notice period. 6 months is still very short given the fact that almost all NBs are heavily overloaded but at least it's 6 months...
Please check the contract you have with the NB which should list reasons for withdrawal of certificates. Normally, e.g. in case a company is unable to timely close certain non-conformitites, the certificate is first suspended. This means that once the non-conformity is closed, the certificate is resumed (no additional audit required). Once it is withdrawn you basically start from scratch.
Depending on the reason for the withdrawal, there is another escape route:
The 55 joint assessments – i.e. international inspections of Notified Bodies (NBs) – performed so far have led to a reduction in the number of European NBs from approximately 80 to fewer than 60. In some instances, the scope of designation of the NBs has also been restricted. This has led to approx. 3,000 EC certificates currently not being monitored by an NB. Many manufacturers are having trouble finding a new NB at short notice in order to get their products certified. This is not an easy process as, currently it may take up to one year to complete. From a regulatory point of view, the validity of EC certificates during this transitional period has not been fully clarified. This raises the question of whether medical devices can continue to be placed on the market for the first time with affected EC certificates. For this reason, a harmonised European procedure has been established and ratified at the end of October in Bratislava.
This foresees that: “...the authorities responsible for market surveillance may, under certain circumstances, grant affected manufacturers a certain period (called the “period of grace” (PoG) in Europe), during which the marketing of safe and effective medical devices affected by the withdrawal of the designation will be tolerated and the manufacturer will be given the opportunity to restore conformity with the regulatory requirements“
In Switzerland (e.g.) the following applies: Within this period, Swissmedic will not take action against the continued placing on the market of medical devices bearing the identification number of the “old” NB provided that the following conditions are met in full:
- Product safety is ensured, i.e. the medical devices covered by the EC certificate represent no known or relevant risk.
- The essential requirements continue to be met in full.
- The manufacturer can demonstrate that the process of renewing the EC certificates of the affected products has been started with a new NB..
- The manufacturer can produce at any time an overview of the affected products/EC certificates and their current status.
For more information:
https://www.swissmedic.ch/aktuell/00673/03691/index.html?lang=enHope this helps!
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Beat U. Steffen
Founder & CEO
confinis ag
Duedingen
Switzerland
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Original Message:
Sent: 04-Apr-2017 15:26
From: Kevin Randall
Subject: Notified Body CE Withdrawal
If there are truly no unresolved Nonconformities associated with your European Technical Documentation/File, EU conformity assessment, and corresponding Declaration of Conformity, then the first things that come to my mind are:
1. Your EC Certificate reached its expiry, but wasn't detected by your organization and/or (less likely) by your NB.
2. There is an urgent marketplace safety issue involving your products.
3. Your NB has lost its recognition as a European NB.
4. Your NB is going out of business or is unable to continue supporting the demands of today's rapidly expanding and evolving EU regulatory landscape.
5. You've received a fraudulent communication intended to trick you.
I can probably give you additional insights if I can get a look at your EC Certificate and the communication you received.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
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Original Message:
Sent: 04-Apr-2017 13:23
From: Anonymous Member
Subject: Notified Body CE Withdrawal
This message was posted by a user wishing to remain anonymous
Hello,
We are a medical device manufacturer in the US and sell a lot of our attachments to the EU. We have passed our yearly audits from our Notified Body with 100% conformity and have not had any issues with our products. Today, without any notice, we received an email from our Notified Body that our CE certificate is being withdrawn as of today. I have reached out to our Notified Body, but no one can say why it is being withdrawn. Does this sound correct? We still have our EN ISO 13485:2012 and ISO 13485:2003 certificates that are under the same Notified Body as our CE and they are still valid. I am extremely worried and am at a loss for what to do since no one can provide me with any answers. Any advice is appreciates. Thank you very much for all of your time.