Declaration of Conformity Template - UKCA Marking

Achieve UKCA marking compliance with our UK MDR (UKCA Marking) Declaration of Conformity Template. Under the UK Medical Devices Regulations 2002 (as amended), manufacturers must provide a Declaration of Conformity (DoC) to demonstrate that their medical device meets essential UKCA marking requirements before placing it on the UK market. This ready-to-use template provides a structured format for drafting a fully compliant Declaration of Conformity, ensuring smooth regulatory approval.

✔ Pre-Formatted Declaration of Conformity Template – Covers key UK MDR (UKCA) requirements.

✔ Manufacturer & Device Identification – Clearly document manufacturer details, device name, and model.

✔ Compliance with Essential Requirements – Confirm adherence to applicable UK MDR safety and performance standards.

✔ Standards & Certification Reference – List harmonized standards and applicable conformity assessment procedures.

✔ Authorised Representative (If Required) – Include details for non-UK manufacturers using a UK Responsible Person.

✔ Notified Body Details (If Applicable) – Reference conformity assessment body involvement for higher-risk devices.

✔ Sign-Off & Official Declaration Statement – Ensure legal compliance with a formal signature and declaration date.

✔ Editable Digital Format – Fully customizable for various medical device classifications.

This UKCA Declaration of Conformity template is ideal for regulatory affairs teams, quality managers, and medical device manufacturers, ensuring a structured, compliant, and efficient UK MDR certification process.

Download the UK MDR (UKCA Marking) Declaration of Conformity Template today and simplify your regulatory compliance journey!