Bassil Akra at TUV SUD is an excellent resource. cc Carmen Asteinza

BSI apparently have the resources, although all will be impacted resource wise by announcement this week by mhra/nb's that own brand labelling is to cease in it's current format in the UK; Obl must now how full tech documents as per the manufacturer

TUV is great.

Hello, you could try TUV SUD UK. Although they are a Germany-based company, they have offices throughout the world. The UK organization web site is:
http://www.tuv-sud.co.uk/

Some of my clients work with an NB based in Ireland called NSAI. Their web site is: http://www.nsaiinc.com/

I think TUV is similar or perhaps larger than BSI in terms of scope and services. NSAI is a smaller group.

Good luck with your project.

Armin Beck Pete if you are firm staying in GB I can not help. But if you are open to other areas contact Medcert a small German NB. They are still taking clients. Anyway the average approval is now 8 month best Armin

Eckhard Jokisch I am sorry for your trouble. It seems that you are one of the "early victims" of either brexit or even the consequences of the upcoming MDR. Only few companies seem to be aware that there will be a significant shortage of NBs soon as it is clear that only 50 to 75 % of the actual NBs will be able to qualify facing the new MDR.

Pete Gaskin Thanks for all the comments, I will give TUV a call.

Michael Wienholt, RAC Be VERY careful when choosing a NB, especially now that the new EU regulations for devices and IVDs are about to be published. Your comment regarding SGS and Intertek are informative, in that not all NB's will be notified to scope and some are already overwhelmed adapting to the changes and the new requirements on NBs. Try to work it out with your existing NB.

BSI

Lewis Lee Perhaps BSI in an option....

I used to have a good relationship with BSI and UKAS.

Try NSAI

I worked for BSI! They are good. I can put you in contact with the right folks in the UK.

I am very happy with BSI. I used to use SGS but same as you , I was told that they do not take on new clients.
BSI was more expensive, but could provide audit date within a reasonable period -4-6 months.

Hello, try TÜV Rheinland, we are present in UK too. I can connect you with my colleagues if you like to check on leadtimes. http://www.tuv.com/en/uk/services_uk/product_testing_uk/medical_devices_uk/medical_products_mdd_1/medical_products_mdd.html

BSI is good for you.

The list of NB is published on the NANDO website. http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&sort=country&dir_id=13

Peter Saalmann As a producer of medical products for Phototherapy I started with TÜV Rheinland in the early 80th (as a kind of heritage of my father) but I was not very satisfied till I changed to LRQA in London and worked together with them for decades, without any negative impressions. It was a real cooperation that I missed with the TUV Rheinland. I worked together with at least three auditors and they were all very good! If you have already started with LRQA you should perhaps insist a bit more that they do their job, in case you think they are too slowly for your needs. You can contact me if you need names though it might be that there are different people in the staff for different subjects...

I may be a tad biased but try LRQA

Beluh Mabasa Ginting just information for all of You. In Indonesia, currently only TUV Nord and TUV Rheinland are Notified Bodies that have been accredited by National Accreditation Body of Indonesia ( KAN) as member of ILAC, IAF, APLAC AND PAC signatory of APLAC/LAC MRA AND PAC/IAF, MLA for a certain scope of medical devices.

Pete Gaskin Brian, we have been with LRQA for over 18 months but we still dont have a date for an audit, hence why we have to change.

BSI and LRQA are your best to work with

From my experience LRQA are by far the best to work with!

We just switched from BSI to UL and have found them to be more responsive. We've only been using them a few months, but I haven't heard any complaints from our regulatory department.

We have been working with MDC and besides the usuall challeges and ongoing discussion back and forwards i have to admit that their stuff is great !
Ms. Sabine and Ms. Julia in particular give us great support and assistance

Marie Suetsugu Am not based in the UK so wouldn't suggest any, but be careful:
By 'TÜV' some people mean TÜV Süd, others TÜV Rheinland (or TÜV Nord or whichever German NB they may be familiar with)...

http://en.wikipedia.org/wiki/Technischer_%C3%9Cberwachungsverein

I have used Inspec (http://www.inspec-international.com) for several years and have found them to VERY good. They are based in the UK so it may be a good match for you. Paul Clarke (managing director) is excellent! Good luck

Nigel Heales CEng MIMechE Have been using LRQA over the past two years and overall fairly impressed with their flexibility etc. Maybe I have been lucky. However I get the impression (industry wide) is that NB's are struggling to meet the demands of the market place and I don't see this improving in the near future. This is coupled with the problem that the "better" ones have even more demand put on them. This forces organisations to better plan and book slots for reviews etc in advance. Easier to change a date than to try and get a quick booking. The other key point is that organisations need to build up a working relationship with the NBs; without stepping over the boundaries of appropriateness etc. When you need help to get you out of a jam, you are more likely to be successful if you are on professionally friendly terms.

Recommend you go with BSI. I have worked with a lot of NB's and the best customer service, technical support and most reliable in my experience is BSI.

Rob Packard I have worked with all of the British NBs in various roles--including working for BSI as an auditor. BSI is the biggest and has more resources for many of the product classifications, but I was very pleased with customer service from LRQA. Unfortunately the product we were working with at that time was a vascular device and LRQA had only 1 technical expert available while BSI had about 10 at that time. Intertek has insufficient resources for all of their clients and I expect they will have difficulty remaining as an NB. SGS has a centralized infrastructure that has held them back, but the internal changes should eventually turn things around. I have not worked with UL recently. I'd love to hear more feedback about their current performance.

Pete Gaskin Not getting anywhere with BSI to be honest. I have phoned them several times now, but still no response. Inspec are not Medical Device Notified Bodies. The only response I have had from any NB's is UL, but their quote was ridiculously expensive. Its as if they all are either too busy or cannot be bothered to respond to sales leads.

You can contract DNV-GL, a Norwegian NB. They have good team of Auidtors

Marie-Catherine SARCIAUX I do not know if you have looked the Nando website, but today there is a trend of Notified Body that are loosing their agreements by Expiration, by Withdrawal... So look at it before to decide .

In addition some NB are part of the Group NBOG that leads the methods for application of new rules related to european directive in relation with Recast.

I have tried to show you the screen about this site from ec europa : nando :
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