Nobel Biocare AB
PO Box 5190, 402 26
Västra Hamngatan 1
Göteborg
411 17
Sweden23 FEB 2024
Notified Body Confirmation Letter
Reference: EU2023-607/793394
To whom it may concern,
Confirmation of the status of a formal application, written agreement, and appropriate
surveillance in the framework of Regulation (EU) 2023/607 amending Regulations (EU)2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical
devices and in vitro diagnostic medical devices
This letter confirms that, BSI Group The Netherlands B.V., a Notified Body (NB) designated against
Regulation (EU) 2017/745 (MDR) and identified by the number 2797 on NANDO, has received a formal
application in accordance with Section 4.3, first subparagraph of Annex VII of MDR and has signed awritten agreement in accordance with Section 4.3, second subparagraph of Annex VII of MDR with thefollowing manufacturer:
Nobel Biocare AB
PO Box 5190, 402 26
Västra Hamngatan 1
Göteborg
411 17
SwedenSRN Number: SE-MF-000000009

BSI Group The Netherlands B.V.
Say BuildingJohn M. Keynesplein 9, 1066 EPAmsterdam, The Netherlands

bsigroup.com
bsigroup.nl
T: +31 20 346 0780

Validity of this letter may be verified by writing to Certificate.Verification@bsigroup.com

MDF7012 rev.0

Page 1 of 16

The devices covered by the formal application and the written agreement mentioned above are identified in
the Tables below. Table 1 identifies the devices for which an MDR application has been received, writtenagreement concluded and for which the NB is also responsible for appropriate surveillance of thecorresponding devices under the applicable Directive. Table 2 identifies the devices for which an MDR
application has been received and a written agreement concluded, but the NB has not yet taken theresponsibility for appropriate surveillance of the corresponding devices under the applicable Directive.
In the case of devices covered by certificates issued under Directive 90/385/EEC (AIMDD) or Directive
93/42/EEC (MDD) that expired after 26 May 2021 and before 20 March 2023, without having been
withdrawn, this letter also confirms that the manufacturer signed the written agreement under MDR by thedate of MDD/AIMDD certificate expiry; or provided evidence that a competent authority of a Member State
had granted a derogation or exemption from the applicable conformity assessment procedure inaccordance with Article 59(1) of MDR or Article 97(1) of the MDR respectively, by the 20 Mar 2023 for therelevant devices.
The transitio
continued compliance to the other conditions specified in Article 120.3c of MDR (as amended by (EU)2023/607), are shown below:
26 May 2026 for Class III custom-made implantable devices
31 December 2027 for Class III devices and Class IIb implantable devices excluding Wellestablished technologies (WET - sutures, staples, dental fillings, dental braces, tooth crowns,screws, wedges, plates, wires, pins, clips and connectors)
31 December 2028 for other Class IIb devices, Class IIa, Class I devices placed on the market insterile condition or have a measuring function
31 December 2028 for devices not requiring the involvement of a notified body under MDD but
requiring it under MDR (e.g., class I devices that qualify as re-usable surgical instruments)

On behalf of BSI Group The Netherlands B.V.,

Graeme Tunbridge
Senior Vice President, Medical Devices

BSI Group The Netherlands B.V.
Say Building
John M. Keynesplein 9, 1066 EP
Amsterdam, The Netherlands

bsigroup.com
bsigroup.nl
T: +31 20 346 0780

Validity of this letter may be verified by writing to Certificate.Verification@bsigroup.com

MDF7012 rev.0

Page 2 of 16