Notified Body Selection Guide

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 BODIES NOTIFIED UNDER DIRECTIVE 93_42_EEC Medical devices 2018-02-06 (PDF)

Note: As of 2018-02-07, there are 59 NBs listed under the 93/42/EEC Medical Device Directive

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)
(IVDR 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

Transfers To BSI

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.