MDR certification

Since May 26, 2021, the EU’s regulation MDR 2017/745 on medical devices has to be applied. This means that all medical devices must comply with these requirements in order to be made available on the European market (provided that the transitional provisions under Article 120 do not apply).

For medical devices in the higher risk classes, manufacturers must engage an impartial third-party reviewer, known as a notified body, to carry out a conformity assessment under MDR 2017/745.

The Swedish Medical Products Agency has designated TÜV NORD Scandinavia MNB as a notified body for medical devices under MDR 2017/745. Our codes can be found in NANDO.

We take decisions on an ongoing basis regarding possible extensions of the scope of our designation. You are therefore welcome to contact us even if your product area is not included in the current scope.

We accept documentation and correspondence in Swedish or English.

For more detailed information, see “Process description for certification public”.

TÜV NORD Scandinavia MNB is accredited by Swedac to issue ISO 13485 certificates.
If you would like to have your quality management system certified according to ISO 13485 in combination with MDR, TÜV NORD Scandinavi MNB offers this.

Use the same form for your ISO 13485 application as for applying for MDR 2017/745 certification.

If you only want ISO 13485 certification, or certification according to other standards, these services are provided by TÜV NORD.