MDSAP Certification Body

MDSAP certification body list for MDSAP certification and Notified Body list for CE Marking as of May 17, 2020.

How to Select an ISO 13485:2016, MDSAP Certification Body

If you only want an ISO 13485:2016 certificate, but you don’t need an MDSAP certificate, you can save time and money by contacting the Eagle Certification Group. Eagle Registrations Inc is accredited by the ANSI-ASQ National Accreditation Board (ANAB) for ISO 9001:2015 and ISO 13485:2016, but they are not an MDSAP Auditing Organization (AO) or a Notified Body (NB). If your company wants to apply for a Canadian Medical Device License, you are required to obtain ISO 13485:2016 certification from one of the recognized MDSAP Auditing Organizations. The FDA maintains a list of these auditing organizations (AOs). There are a total of 16 AOs on the list. However, only 12 of the AOs are also designated by European Member States as Notified Bodies (NBs) responsible for CE Marking Medical Devices. Below is our list of the AOs that are also NBs (in alphabetic order), and only 16 of the 49 NBs (30%) are designated under the new EU MDR. According to the European Commission, 44 NBs have applied for designation under the new EU MDR, but the Turkish NBs were not included in count total of 49 NBs listed above.

1. *BSI Group (Designated under new EU MDR – NB No. 0086 & 2797)
2. *Dekra Certification (Designated under new EU MDR – NB No. 0124 & 0344)
3. *DNV GL Presafe (Designated under new EU MDR – NB No. 2460)
4. DQS MED (Designated under new EU MDR – NB No. 0297)
5. *LNE/GMED (Designated under new EU MDR – NB No. 0459)
6. Intertek (Designated under new EU MDR – NB No. 0413)
7. MED/CERT (Designated under new EU MDR – NB No. 0482)
8. *NSAI (Designated under new EU MDR – NB No. 0050)
9. *SGS (Designated under current MDD – NB No. 0120 & 1639)
10. *TUV Rheinland (Designated under new EU MDR – NB No. 0035)
11. *TUV SUD (Designated under new EU MDR – NB No. 0123)
12. TUV NORD (Designated under current MDD – NB 0044)

*MDSAP Certification Bodies that have applied for designation under IVDR

Of the 12 AO’s above that are also NBs, only 8 NBs have applied for designation under the IVDR, and only 2 have received designation:

1. BSI Group – Designated under IVDR – NB No. 0086 & 2797
2. Dekra Certification – Designated under IVDR – NB No. 0124 & 0344
3. DNV GL Pre-Safe – Awaiting designation under IVDR – NB No. 2460
4. LNE/GMED – Awaiting designation under IVDR – NB No. 0459
5. NSAI – Awaiting designation under IVDR – NB No. 0050
6. SGS – Awaiting designation under IVDR – NB No. 0120 & 1639
7. TUV Rheinland – Awaiting designation under IVDR – NB No. 0035
8. TUV SUD – Awaiting designation under IVDR – NB No. 0123

Interviews with MDSAP Certification Bodies

As part of our research for our book on remote auditing techniques, we will be interviewing each of the 12 MDSAP Certification Bodies listed above. Our goal is to learn about the remote auditing policies that each of these MDSAP Certification Bodies have implemented during the COVID19 pandemic. We also will be providing a list of contact information for the contact(s) at each MDSAP Certification Body in order to obtain a quotation for initial MDSAP Certification.