So many people ask me for Notified Body (NB) selection advice that I decided to get a little organized.
Companies shopping for Notified Bodies should have courtship with at least 3 candidates. The tips below should help you to determine who is qualified to be your Notified Body based on the applicable product ranges and regulatory paths.
Click here to view the content below in a PDF document.
Initial Screening Tips
Step 1
Determine which organizations are considered NBs under the applicable current European Directive, and which NBs are authorized to perform conformity assessments for your type of devices (based on product codes indicated for each NB vs. your product codes).
Search engine for NBs and product listings under current Directives (leads to “Notification” document for each NB that lists applicable Directives, Annexes, products they are allowed to certify)
List of Notified Bodies (and associated product codes) under Medical Device Directive 93/42/EEC
List of Notified Bodies under Europe Medical Devices Regulation (EU) 2017/745
List of Notified Bodies under Europe In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
Step 2
Consider NBs who are members of Team-NB. Membership on Team-NB demonstrates commitment.
Note: As of 2018-02-07, there are 24 NB members on Team-NB.
Step 3
To see which Team-NB members are applying for designation under the new European MDR and IVDR, see this 2017-12 list published on the Team-NB website. Check Team-NB website for updates.
Step 4
Cross-check candidate NBs against this list of “Auditing Organization Availability to Conduct MDSAP Audits”. The AOs involved with MDSAP include the largest and most committed NBs, and a few organizations who are not NBs. Check FDA MDSAP website to get future updates for this list.
Screening Table
This table is based on information obtained from the sources identified above, as of the date of this NB Selection Guide.
| Auditing Organization/ Notified Body Name (hyperlink) Notified Body ID Number |
HQ Location (Country) |
USA Office Location (City, State) |
Team-NB List
(MDR Application) |
MDSAP Status as of 2017-12 |
Remarks |
| BSI Product Certification 0086 |
UK | Herndon, VA | MDR – Yes
IVDR – Yes |
Authorized – Yes
Recognized – Yes |
Brexit Home Page |
| DARE!! Medical Certifications 1912 |
NL | MDR – Yes
IVDR – No |
———- | ||
| DEKRA Certification BV 0344 |
NL | North Wales, PA Concord, CA |
MDR – Yes
IVDR – Yes |
Authorized – Yes
Recognized – No |
|
| DEKRA Certification GmbH 0124 |
D | North Wales, PA Concord, CA |
MDR – Yes
IVDR – Yes |
———- | |
| DNV Nemko Presafe AS 2460 |
NO | MDR – Yes
IVDR – No |
Authorized – Yes
Recognized – No |
||
| DQS Medizinprodukte GmbH 0297 |
D | MDR – Yes
IVDR – No |
Authorized – Yes
Recognized – No |
||
| EKAPTY SA 0653 |
GR | MDR – Yes
IVDR – No |
———- | ||
| Ente Certificazione Macchine Srl. 1282 |
IT | MDR – Yes
IVDR – Yes |
———- | ||
| Intertek AMTAC Certification Services 0473 |
UK | MDR – Yes
IVDR – No |
———- | ||
| Intertek Semko 0413 |
S | MDR – Yes
IVDR – No |
———- | ||
| Intertek Testing Services NA Inc. (not a Notified Body) |
USA | Lowell, MA | Not on List | Authorized – Yes
Recognized – Yes |
|
| Kiwa 1984 |
TR | MDR – Yes
IVDR – No |
———- | ||
| LNE/G-MED 0459 |
F | Bethesda, MD | MDR – Yes
IVDR – Yes |
Authorized – Yes
Recognized – No |
|
| LRQA 0088 |
UK | MDR – Yes
IVDR – Yes |
Authorized – Yes
Recognized – No |
||
| LRQA Inc. (subsidiary of LRQA 0088) |
USA | Houston, TX | Not on List | Authorized – Yes
Recognized – No |
|
| mdc medical device certification 0483 |
D | MDR – Yes
IVDR – Yes |
———- | ||
| MEDCERT 0482 |
D | MDR – Yes
IVDR – No |
———- | ||
| NSAI 0050 |
IRL | Nashua, NH | MDR – Yes
IVDR – Yes |
Authorized – Yes
Recognized – No |
|
| NSF Health Sciences Certification, LLC (not a Notified Body) |
USA | Washington DC | Not a Notified Body | Authorized – Yes
Recognized – No |
NSF 2018-02-08 press release indicates recognition received |
| Presafe Denmark A/R 0453 |
DK | MDR – Yes
IVDR – Yes |
———- | ||
| SAI GLOBAL (not a Notified Body) |
CA | Not on List | Authorized – Yes
Recognized – No |
||
| SGS 0120 |
UK | MDR – Yes
IVDR – Yes |
Authorized – Yes
Recognized – Yes |
||
| SIQ Ljubljana 1304 |
SL | MDR – Yes
IVDR – No |
———- | ||
| SZUTEST 2195 |
TR | MDR – Yes
IVDR – No |
———- | ||
| TÜV Nord Cert. 0044 |
D | MDR – Yes
IVDR – No |
———- | ||
| TÜV Rheinland LGA Products 0197 |
D | MDR – Yes
IVDR – Yes |
———- | ||
| TÜV Rheinland of North America, Inc (subsidiary of TUV Rheinland 0197) |
USA | Newtown, CT Pleasanton, CA |
Not on List | Authorized – Yes
Recognized – No |
|
| TÜV SÜD 0123 |
D | MDR – Yes
IVDR – Yes |
———- | ||
| TÜV SÜD America Inc (subsidiary of TUV SUD 0123) |
USA | Peabody, MA | Not on List | Authorized – Yes
Recognized – Yes |
|
| TÜV USA, Inc (not a Notified Body) |
USA | Salem, NH | Not on List | Authorized – Yes
Recognized – No |
|
| UL International Limited 0843 |
UK | MDR – Yes
IVDR – Yes |
———- | Not designated for implants or Class III devices | |
| UL Medical and Regulatory Services UL, LLC
(partnered with UL International 0843) |
USA | Northbrook, IL Fremont, CA |
Not on List | Authorized – Yes
Recognized – Yes |
Once you have come up with your short-list, then you should start calling the candidates. Why call? Because some of them are so busy they are not answering emails in a timely fashion. And beware that some of the busier Notified Bodies have a new client backlog that means your Stage 1 audit may not be scheduled for up to 6 months after you sign an agreement.
Here is an older blog post related to NB selection that is still mostly good advice. However, it is generally no longer possible to interview your prospective Lead Auditor in advance of engaging the NB. And while I love the NB business development people, they tend to say lots of weird stuff just to get your business!
Changing Notified Bodies?
Ensure that 3-way transfer agreement is executed between Manufacturer, Previous Notified Body, and Subsequent Notified Body. Contact me for a template.
