The declaration of conformity shall as a minimum contain all of the information stated in Annex IV of the MDR / IVDR, and shall be available to the competent authorities.
The manufacturer shall continuously update the EU declaration of conformity. In Norway, a declaration of conformity must be given in English or Norwegian.
If a device in addition to the MDR is subject to other EU regulations that also require a declaration of conformity, one declaration of conformity shall be drawn up in respect of all of the EU acts applicable to the device. The declaration of conformity shall contain all the information required for identification of the EU legislation to which the declaration relates.
MDR and IVDR state the rules for determining risk classes, see additional information under Classification (in Norwegian). It is the manufacturer's responsibility to determine whether the device must be reclassified or assessed by a notified body.
Read more about Transitional provisions
What shall the EU declaration of conformity contain?
- Company name, contact information and Single Registration Number (SRN), authorised representative
- A statement regarding the manufacturer’s sole responsibility
- The Basic UDI-DI
- Device and company name, device code, catalogue number or other unambiguous reference
- Risk class of the device cf. Annex VIII
- A statement regarding conformity with MDR or IVDR, and, if applicable, with any other relevant EU legislation
- A statement regarding conformity with common specifications, if applicable
- The name and identification number of the notified body and certificates issued, if applicable
- Additional information, if applicable
- Place, date, signature, name and function of the person who signed
For additional information, see Annex IV in MDR and IVDR.
For declarations of conformity issued under the directives for:
- Active implantable medical devices (90/385/EEC)
- Medical devices (93/42/EC)
- In vitro-diagnostic devices (98/79/EC)
The content is as described in Blue Guide section 4.4.