Page Last Reviewed: 2 January 2024
After a manufacturer has successfully completed the CE Marking process, they must sign a Declaration of Conformity (DoC). This is a legally binding document, in which the manufacturer asserts that they have met the minimum requirements of the applicable legislation.
Manufacturers of systems/procedure packs and custom-made devices must also draw up statements.
Below we provide the medical device & IVD Declaration of Conformity requirements in Europe, the United Kingdom, and Switzerland.
Unlike in the old Directives, the MDR/IVDR provides explicit instruction on the information to be included: MDR Article 19 & Annex IV and IVDR Article 17 & Annex IV.
At minimum, the DoC shall contain:
*A DoC may contain more than one Basic UDI-DI.
**Except for the product name / trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI.
The Directives do not explicitly outline the minimum requirements of the Declaration of Conformity. Instead, manufacturers must extrapolate requirements from the Directives and refer to Council Decision 768/2008/EC. The Blue Guide* is also useful to understand minimum expectations.
At minimum, the DoC should contain:
*The Blue Guide “is intended purely as a guidance document – only the text of the Union harmonization act itself has legal force.” However, it still remains a valuable reference in interpreting European legislation.
Legacy devices are those that are legally allowed to be placed onto the European market under the under MDD/AIMDD/IVDD CE Marking, after the MDR/IVDR dates of application have passed.
To qualify as a legacy device, it must have been CE marked, with a DoC drawn up, before the 26 May 2021 (MDR) or 26 May 2022 (IVDR).
To remain a legacy device, no significant changes can be made to the design or intended purpose. Otherwise, the device may need to comply with the new Regulation. However, non-significant changes can be made. For example, changes to the manufacturer’s name or address.
Further, the DoC should not be modified or reissued. At the same time, DoCs may begin to reflect outdated information if it cannot be amended. So how do manufacturers address this issue?
MDCG 2020-3 Rev.1, guidance on significant changes to legacy medical devices, advises on how changes to a CE Certificate can be noted:
“The certificate should not be amended. However, the notified body that issued the certificate in accordance with the AIMDD/MDD may confirm in writing, after having reviewed the manufacturer’s description of the (proposed) change, that the implementation of the change does not represent a significant change in design or intended purpose under Article 120(3c), point (b) MDR and that the related AIMDD/MDD certificate remains valid until the end of the transition period. Such written confirmation corrects or complements information on an existing certificate but does not represent the issuance of a “supplemented certificate”, since this is prohibited as mentioned in Section 3. In case of requests from authorities, the manufacturer should number such letters16 received from the notified body and submit them together with the certificate.
16In case of class I devices (not certified by a NB), manufacturers may also drawn up a statement listing non-significant changes performed to the device. This statement could accompany the Declaration of conformity previously issued.”
Therefore, manufacturers may issue a written statement of the change, and that it does not represent a significant change to the design or intended use. That statement could then be provided with the original DoC.
For more information, please read: What are Legacy Devices?
The MHRA’s current medical device and IVD Regulation is based on the old Directives , e.g., the Medical Devices Directive (MDD) 93/42/EEC.
The UK had long ago transposed the MDD into national law, along with the other EU member states. However, the UK withdrew from the EU and was no longer an EU member state when the MDR went into effect. Instead, the MHRA is developing their own updated medical device and IVD legislation. The new legislation will apply in Great Britain only, as Northern Ireland requires, and will continue to require, CE marking.
For more information about the UK’s proposed new regulation, please read: New Dates for UK Regulation & CE Marking
In the meantime, since the UK Medical Device Regulation is based on the old Directives, manufacturers can follow the requirements as outlined in the above EU Declaration of Conformity – MDD/AIMDD/IVD section, with the following amendments:
Regarding harmonized standards, the UK’s current list still references the EU standards. The MHRA’s current list of recognized standards is available: HERE
Manufacturers must draft a statement, meeting the minimum requirements of MDR, Annex XIII, Section 1:
Per the MHRA’s Guidance on Custom-made devices in Great Britain, manufacturers must draw up a statement, which must at minimum include:
The MHRA also provides PDF examples of custom-made statements: HERE
System/Procedure Packs are not CE marked but may contain CE marked devices within the system or procedure pack.
System – a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose
Procedure pack – a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose
Per MDR Article 22(1), the System or Procedure Pack producer must draw up a statement if they combine CE marked devices with:
The minimum requirements in the statement, per MDR Article 22(1)(a)-(c):
Comprehensive guide to Systems, Procedure Packs and Kits, and the requirements in Europe, Switzerland and the UK.
As with the above section related to the UK Declaration of Conformity, the UK’s System / Procedure Pack requirements are based on the old Directives.
Section 14(1)(b) of the UK MDR 2002 states that “the person who places or has placed it on the market has drawn up a declaration that—
(i) he has verified the mutual compatibility of the medical devices in that system or procedure pack in accordance with the manufacturers’ instructions, and he has carried out his operations in accordance with these instructions,
(ii) he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers, and
(iii) his production of the system or procedure pack is subjected to appropriate methods of internal control and inspection,
and that declaration is true at the time it is made and continues to be true.”
Please read all of Section 14 for further requirements related to systems, procedure packs and devices to be sterilized before use.
Swissmedic currently accepts the EU Declaration of Conformity and does not require amendments to meet the Swiss Medical Device (MedDO) or IVD (IvDO) Ordinances.
This is addressed in the ‘Market Access/Conformity Assessment’ section of their FAQ page: HERE
“Note: No Switzerland-specific documentation on conformity is required, i.e. stating the CHRN, the Swiss authorised representative or the Medical Devices Ordinance on the certificates of conformity is not mandatory.”
The FAQ page does not explicitly state the same consideration applies for system, procedure pack statements or for custom-made device statements. However, the FAQ’s sections on systems and procedure packs and custom-made devices reference the MDR for minimum requirements and do not state that any adjustments are required to further meet the Swiss ordinances.
Casus has editable Declaration of Conformity templates available in word format: HERE