Update: New 2022 Version of Blue Guide Released
4 August 2022
Proposed Classifications for Products without a Medical Intended Purpose
12 August 2022
- Declaration of Conformity – MDR/IVDR
- Declaration of Conformity – MDD/AIMDD/IVDD
- Declaration of Conformity – UKCA
- Custom-made Device Statement – Europe
- Custom-made Device Statement – UK
- System/Procedure Pack Statement – Europe
- Systems/Procedure Packs
- System/Procedure Pack Declaration – UK
- Declarations/Statements – Switzerland
- Free Templates
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.
Declaration of Conformity – MDR/IVDR
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:
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- Economic Operators:
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- Manufacturer name & address, including registered trade name or registered trademark of manufacturer
- Authorized Representative name & address
- Single Registration Number (SRN) for manufacturer and authorized representative, if available
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- Basic UDI-DI*
- Product information:
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- Product name and trade name
- Product code(s), catalogue number(s) or other unambiguous reference** allowing identification and traceability of the devices covered within the DoC
- Intended purpose
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- Notified Body information, if applicable:
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- Name and identification number
- Identification of the certificate(s) issued
- Description of the conformity assessment procedure performed
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- Device risk classification
- Conformity assessment route
- References to any common specifications applied to the device
- Statements:
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- That the ‘EU declaration of conformity is issued under the sole responsibility of the manufacturer’
- That the device in the DoC is in conformity with the MDR/IVDR and, if applicable, with any other relevant EU legislation that requires a DoC issued, e.g., RoHS
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- Where applicable, additional information
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- This can include harmonized standards, which are voluntary; however, when used, the device/manufacturer be presumed to comply
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- Signatory:
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- Place and date of issue of the Declaration
- Name and function of the person who signed it, as well as an indication for, and on behalf of whom, that person signed
- Signature
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- Economic Operators:
Additional Requirements
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- Continuously update the DoC as needed
- Translate the DoC into an official EU national language, or languages required by the Member State(s) in which the device is made available
- If device is subject to other legislation which also requires a DoC, a single DoC will be drawn up containing all the information required for identification of the Union legislation to which the declaration relates, e.g., Restriction of Hazardous Substances (RoHS) 2002/95/EC
*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.
Declaration of Conformity – MDD/AIMDD/IVDD
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:
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- Manufacturer name and address
- Authorized Representative name and address
- Notified Body name and number
- Product information:
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- Product Name
- Product identification, allowing traceability
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- Device classification
- Conformity assessment route
- References to relevant harmonized standards used or other technical specifications
- Statements:
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- That the DoC is issued under the sole responsibility of the manufacturer
- That the product is in conformity with the relevant legislation (e.g., Council Directive 93/42/EEC)
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- Signatory:
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- Name & title
- Date and place of issue
- Signed for and on behalf of: ………….
- Signature
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Additional Considerations
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- Blue Guide recommends the DoC:
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- Should be continually updated as changed
- Be translated into the language or languages required by the Member State in which the product is placed or made available on the market
- A single DoC is required whenever a product is covered by several pieces of union harmonization legislation requiring an EU DoC
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- Note, Council Directive 768/2008/EC also states that where multiple legislations apply to a device which require a DoC, they should be combined into a single DoC
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- Blue Guide recommends the DoC:
*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.
Special Considerations for Legacy Devices
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 (medical devices) 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.”
The corresponding guidance for IVDs is MDCG 2022-6.
Further, MDCG 2020-2 Rev.1 (Class I transitional provisions under MDR Article 120) states:
“Every Declaration of Conformity must be based on proper technical documentation according to Annex VII paragraph 3 of the MDD. … Necessary amendments/updates to the technical documentation should be done in a transparent manner. Both the changes and the dates of when the changes were made should be recorded.
On the basis of the Declaration of Conformity and the corresponding technical documentation, the manufacturer should be able to demonstrate that the Declaration of Conformity was lawfully issued before 26 May 2021 and that, subsequently, there are no significant changes in the design or intended purpose in the meaning of Article 120(3) MDR.”
The corresponding guidance for IVDs is MDCG 2022-15.
Therefore, manufacturers may issue a written statement of the change, and note 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?
Declaration of Conformity – UKCA
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:
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- The legislation referenced should be the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), instead of the MDD/AIMDD/IVDD
- UKCA marking referenced, instead of CE marking
- UK Responsible Person referenced, instead of a European Authorized Representative
- UK Approved Body identified, instead of the EU Notified Body
Regarding harmonized standards, the UK’s current list still references the EU standards. The MHRA’s current list of recognized standards is available: HERE
Custom-made Device Statement – Europe
Manufacturers must draft a statement, meeting the minimum requirements of MDR, Annex XIII, Section 1:
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- the name and address of the manufacturer, and of all manufacturing sites
- if applicable, the name and address of the authorised representative
- data allowing identification of the device in question
- a statement that the device is intended for exclusive use by a particular patient or user, identified by name, an acronym or a numerical code
- the name of the person who made out the prescription and who is authorized by national law by virtue of their professional qualifications to do so, and, where applicable, the name of the health institution concerned
- the specific characteristics of the product as indicated by the prescription
- a statement that the device in question conforms to the general safety and performance requirements set out in Annex I and, where applicable, indicating which general safety and performance requirements have not been fully met, together with the grounds
- where applicable, an indication that the device contains or incorporates a medicinal substance, including a human blood or plasma derivative, or tissues or cells of human origin, or of animal origin as referred to in Regulation (EU) No 722/2012
Custom-made Device Statement – UK
Per the MHRA’s Guidance on Custom-made devices in Great Britain, manufacturers must draw up a statement, which must at minimum include:
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- data allowing identification of the device in question, i.e. description, serial number, order number, generic name
- a statement that the device is intended for exclusive use by a particular patient, together with the name of the patient (this may be an identification number if patient confidentiality needs to be maintained, provided it can be traced through records to the named patient)
- the name of the qualified person, medical practitioner or other authorised person who made out the prescription and, where applicable, their place of work
- the particular features of the device as specified in the relevant prescription, i.e. the written prescription with its special features extracted to define the particular device
- a statement that the device in question conforms to all the relevant essential requirements and, where it does not, the grounds for believing it is safe for use
- the name and address of the manufacturer
The MHRA also provides PDF examples of custom-made statements: HERE
System/Procedure Pack Statement – Europe
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:
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- Other CE marked devices
- IVD CE marked devices
- other products used within a medical procedure or where their presence in the system/procedure pack is otherwise justified; products must be in conformity with legislation that applies to them
The minimum requirements in the statement, per MDR Article 22(1)(a)-(c):
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- They have verified that the products are mutually compatible in accordance with the manufacturer’s instructions for use and they have carried out their activities in accordance with those instructions
- They have packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products that have been put together
- The activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation
Systems/Procedure Packs
Comprehensive guide to Systems, Procedure Packs and Kits, and the requirements in Europe, Switzerland and the UK.
System/Procedure Pack Declaration – 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.
Declarations/Statements – Switzerland
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.
Free Templates
Casus has editable Declaration of Conformity templates available in word format: HERE
