CE Certificate Expiring and NB unable to extend / renew as not in their scope as a NB

A

AlanPG

#1
We are a small company that holds an OBL Medical Device EC Certificate for some class IIa and IIb devices. Our certificate is due to expire shortly and we have been trying to renew / extend it. Unfortunately our NB (AMTAC / Intertek) has been ignoring our correspondence since April.

We then recently wrote to the MHRA who contacted our NB and all of a sudden the NB emailed to say that they could not issue a new certificate as this was no longer within their scope of designation as a NB but " We are working closely with MHRA to determine the way forward for the transition."

Has anyone had experience of this? We are now stuck trying to migrate to a new NB with only a few weeks before our current certificate expires.

Many thanks

Alan
 
Elsmar Forum Sponsor

RobertvanBoxtel

Involved In Discussions
#2
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Not sure on the specifics here with Amtac/intertek, but it is known that UK NB's are treating OBL constructions very black and white, meaning: OBL is not a term under the MDD and we will treat you as a regular manufacturer. This will require you to have all technical documentation on the product available. Any formerly issued certificates that identify wording along the way of "under OBL construction" will not be re-issued anymore.

Sorry, I realize my answer does not help you in your situation, you will have to move anyway if they are not responding.:(
 

SteveK

Trusted Information Resource
#3
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

I wonder if this relates to the new Medical Device Regulations i.e. the reference to “the transition”. These have not been officially published, but will now require an OBL company to have full Technical Files (as Robert indicated), which I suspect you do not have (not a requirement for an OBL currently). Even when official published in the EU journal (2017?) there will be a three year transition period, so under the current MDD93/42/EEC you should still comply with the requirements for having a new certificate issued (assuming your last audit was OK). This does therefore seem very odd - though Roberts' insight about UK NBs is not something I am aware of. I would suggest you get back to the MHRA as I think your NB is not meeting its current obligations to you as a company.

Steve
 

RobertvanBoxtel

Involved In Discussions
#4
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Most likely indeed there is a link to what is being negotiated in the MDR at the moment, CA's already imposing it on their NB's. The MHRA intended to write a guidance document on OBL and got "corrected" by the European Commission on this. As a result, they moved to the other extreme, strictly enforcing the Commission Recommendation 2013_473_EU on how NB should assess compliance.
And they follow it strictly resulting in no more OBL constructions.
 
A

AlanPG

#5
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Thank you Robert and Steve for your messages.

The MHRA have informed us that our NB should get back to me this week with further details.

Are all NBs not extending these types of OBL certificates?

Should they have not given us reasonable notice of this?

Many thanks

Alan
 
A

AlanPG

#6
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Further to my last post, I have just reviewed our last audit and it appears to be following 2013/473/EU recommendations including technical file review and unannounced audits of our subcontractors etc. It was following this audit that we had to make some changes in our QMS to allow for these recommendations eg amending our agreement with our subcontractor to allow for unannounced audits and providing further manufacturing details in our technical file.

It appears to me that there is more to this and it relates specifically to our NB rather than the NBs in general.

Many thanks in advance.
 

SteveK

Trusted Information Resource
#7
A

AlanPG

#9
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Thank you Steve and Ronen.

What is strange is that the devices are still listed within their scope. But the MHRA wrote to us yesterday with regards to AMTAC and said:

Dear Alan,

You should hear from them this week. All will be clear once they contact you.

You may deal with a new Notified Body to progress on that front but also await feedback from your existing notified body regarding your certificate.

Kind regards


So we will have to wait and see.
 

SteveK

Trusted Information Resource
#10
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Hi Alan,

As pointed out in another forum last year, the European Commission reported that not everything in NANDO is up to date as it should be. If you have not done so already, check out NBOG Best Practices Guide 2006-1 on changing NBs.

http://www.nbog.eu/resources/NBOG_BPG_2006_1.pdf

Regardless, I hope things work out for you.

Steve
 
Thread starter Similar threads Forum Replies Date
D Selling Medical Device Abroad After the Expiring Date of the EC Certificate EU Medical Device Regulations 5
C Lapse between ISO 13485 certificate expiring and new audit ISO 13485:2016 - Medical Device Quality Management Systems 9
A Is it mandatory to obtain ISO13485 certificate prior to CE marking? EU Medical Device Regulations 8
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
A How to make sure whether the predicated device is marked with EC certificate? EU Medical Device Regulations 8
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Certificate Suspension? Shut down due to Covid-19 IATF 16949 - Automotive Quality Systems Standard 14
L Appears to be a certificate mill certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D ISO 9001 & AS9100 Certificate issued by a consultant for a Distributor Registrars and Notified Bodies 11
J CE Certificate and additional processing EU Medical Device Regulations 4
bryan willemot Chemical / physical certificate of conformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B IATF certificate suspended - Who do we notify? IATF 16949 - Automotive Quality Systems Standard 6
F Calibration certificate content - Average Value and True Value ISO 17025 related Discussions 6
H What is different between PED certificate and CPR certificate? Manufacturing and Related Processes 2
C Migrate ISO 9001:2015 Certificate Registrars and Notified Bodies 4
M How to read a calibration certificate for thermo hygrometer General Measurement Device and Calibration Topics 2
V Calibration certificate verification Qualification and Validation (including 21 CFR Part 11) 3
A Calibration Certificate Results General Measurement Device and Calibration Topics 3
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
E Calibration Certificate Content Requirements General Measurement Device and Calibration Topics 3
M IATF 16949:2016 clause 8.4.2.3 - We don't have ISO 9001:2015 certificate IATF 16949 - Automotive Quality Systems Standard 26
S Boeing D6-51991 Product Acceptance Software certificate and Artefact? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
J COC (Certificate of Conformity) when NOT purchasing medical devices direct from the Manufacturer Other Medical Device Related Standards 2
P List of ISO certificate registrars around the world - ISO certification databases ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
F EC in EC certificate - Is it an EC Certificate or a CE certificate? CE Marking (Conformité Européene) / CB Scheme 3
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate Qualification and Validation (including 21 CFR Part 11) 3
K Inspection Certificate EN 10204 2.1 - Distribution company Other ISO and International Standards and European Regulations 4
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate General Measurement Device and Calibration Topics 2
R Certificate of compliance to RoHS/REACH/WEEE - any such animal? REACH and RoHS Conversations 18
D CB Certificate - Distributor for a product with electrical components CE Marking (Conformité Européene) / CB Scheme 4
P Non-Active Suppliers on CE Certificate EU Medical Device Regulations 2
A Interpretation of Article 16 (2b) - Packaging, samples and Certificate EU Medical Device Regulations 10
R List of countries that require only CE Mark certificate for product registration Other ISO and International Standards and European Regulations 2
K CFG (certificate of foreign government) Requestor Other US Medical Device Regulations 0
H Transferring an ISO 13485 certificate to a new CB - Do I have to start from scratch? ISO 13485:2016 - Medical Device Quality Management Systems 2
GStough Informational SN EN ISO 9001:2015 and SN EN ISO 13485:2016 on Same Certificate? Registrars and Notified Bodies 7
M We still have not received our certificate due to a 'backlog' with our auditing body Registrars and Notified Bodies 25
T CE Certification Strategy - Expanding the validity of certificate EU Medical Device Regulations 1
T EN 10204 3.1 Inspection Certificate - Machine Shop Various Other Specifications, Standards, and related Requirements 4
G Is the calibration due date of equipment used to be on calibration certificate ISO 17025 related Discussions 38
M Informational EU – MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers Medical Device and FDA Regulations and Standards News 0
I Document Signature Software? (Certificate Authorities) Document Control Systems, Procedures, Forms and Templates 15
N PPAP material certificate date IATF 16949 - Automotive Quality Systems Standard 4
howste Merging sites on one AS9100 certificate - expiration date? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
B Integrated management system - ISO 9001 and ISO 14001 - Is possible to have a joint certificate covering both standards? ISO 14001:2015 Specific Discussions 6
T Software Validation Certificate (ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 19
noratkhen Eligibility to get a IATF 16949 certificate for a Tier N>3 supplier? IATF 16949 - Automotive Quality Systems Standard 25
Sidney Vianna Interesting Discussion Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate? Canada Medical Device Regulations 0

Similar threads

Top Bottom