Declaration of Conformity Template UK and EU
Declaration of Conformity Template: UK and EU
If you’re a medical device manufacturer looking to market your products in the UK or EU, preparing a Declaration of Conformity (DoC) is a critical step in the regulatory process. This document is a formal statement by the manufacturer declaring that their device meets all applicable regulatory requirements. While the purpose of the DoC is similar in the UK and EU, the details vary slightly due to differences in their regulatory frameworks.
In this post, we’ll explore the purpose of a Declaration of Conformity, key differences between the UK and EU requirements, and provide a template to get you started.
What is a Declaration of Conformity?
A Declaration of Conformity is a legally required document that certifies your medical device complies with relevant legislation and standards. It’s issued by the manufacturer under their sole responsibility and forms part of the device’s technical documentation.
In the UK, the DoC must comply with the UK Medical Device Regulations 2002 (as amended), while in the EU, it must meet the requirements of the Medical Device Regulation (MDR 2017/745) or In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746).
Key Differences Between the UK and EU Declarations
AspectUK (UKCA Marking)EU (CE Marking)Applicable LegislationUK Medical Device Regulations 2002 (as amended)MDR 2017/745 or IVDR 2017/746MarkingUKCA (UK Conformity Assessed) MarkCE MarkResponsible PartyUK Manufacturer or UK Responsible PersonEU Manufacturer or Authorized RepresentativeNotified BodyRequired for higher-risk devices, with UK-approved Notified BodyRequired for higher-risk devices, with EU-designated Notified Body
While the structure and content of the DoC are largely similar, manufacturers must ensure they align the language and references to the applicable standards and legislation for the specific market.
Key Components of a Declaration of Conformity
Both UK and EU Declarations of Conformity typically include the following:
Manufacturer Details: Name, address, and contact information.
Authorised Representative: If applicable, details of the UK Responsible Person (UKRP) or EU Authorised Representative.
Device Details: Product name, model or reference number, and classification.
Applicable Legislation: Declaration of compliance with relevant UK or EU legislation.
Standards: A list of applicable harmonized or designated standards (e.g., ISO 13485, ISO 14971).
Place and Date of Issue: Location and date the declaration was issued.
Authorized Signature: Name, title, and signature of the person authorized to sign on behalf of the manufacturer.
Declaration of Conformity Template for UK
Here’s a sample template tailored for UK requirements:
UK Declaration of Conformity
Manufacturer Name: [Your Company Name]
Manufacturer Address: [Your Company Address]
Product Name: [Device Name]
Model Number(s): [Model Numbers]
Risk Classification: [Class I, IIa, IIb, III]
Applicable Legislation: UK Medical Device Regulations 2002 (as amended)
Standards Applied: [E.g., ISO 13485, ISO 14971]
UKCA Certificate Number (if applicable): [Certificate Number]
UK Approved Body (if applicable): [UK Approved BodyName and ID]
Place and Date of Issue: [City/Country], [Date]
Name and Position of Signatory: [Authorised Name], [Job Title]
Signature: _______________________
Declaration of Conformity Template for EU
For EU markets, use this example:
EU Declaration of Conformity
The EU declaration of conformity shall contain all of the following information:
1.Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in Article 31 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established;
2.A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
3.The Basic UDI-DI as referred to in Part C of Annex VI;
4.Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3;
5.Risk class of the device in accordance with the rules set out in Annex VIII;
6.A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;
7.References to any CS used and in relation to which conformity is declared;
8.Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;
9.Where applicable, additional information;
10.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.
Final Thoughts
The Declaration of Conformity is more than just a document—it’s your assurance that your medical device meets all the necessary requirements for market entry. Getting it right is critical to avoid delays or penalties.
At The Other Consultants, I specialize in helping manufacturers navigate the complexities of regulatory compliance. Whether it’s preparing a Declaration of Conformity, managing UKCA or CE marking, or liaising with regulatory bodies, I’m here to simplify the process for you.
Contact me today to learn how I can help streamline your regulatory journey for both the UK and EU markets.