Writing the Declaration of Conformity: MDA Requirements Item by Item

1. Key takeaways

The Declaration of Conformity is a statement of fact that has to be backed by facts. The DoC is the written document in which the manufacturer declares that the device complies fully with all applicable Essential Principles of Safety and Performance. It is one of the four elements of conformity assessment under the Third Schedule to MDR 2012, and for Class A registration it is the central document, because the assessment rests on the declaration and its supporting evidence rather than on a full technical review.

Because the DoC is short, it attracts less attention than it deserves. The statutory content is narrow — who the manufacturer is, what the device is, and who signed — but the document only works if each statement can be traced to supporting material. A CAB does not verify the DoC by reading it; it verifies the DoC by testing whether the claims inside it survive contact with the evidence behind it.

• Function: manufacturer declaration of full compliance with all applicable EPSP.
• Status: one of the four elements of conformity assessment in the Third Schedule.
• Weight: the core document for Class A registration.
• Statutory content: manufacturer name and address, device particulars including name and classification, and the name, position and signature of the responsible person.
• Practical content: EPSP relied on, list of applicable standards, date of issue.
• Signature: an authorised senior officer of the manufacturer; an overseas manufacturer submits through the authorised representative.

2. Legal basis

The Third Schedule to MDR 2012 identifies the DoC as an element of conformity assessment, which is why the document is examined as evidence rather than accepted as a formality. The statutory elements are prescribed, and the MDA industry guidance on the Declaration of Conformity explains how the document is to be completed and what a CAB is expected to check. The points that matter in practice are summarised below.

The verification standard is stated plainly in the framework: the CAB confirms the sufficiency of the DoC by reviewing supporting documents or other evidence, including test reports and the applicable standards. Sufficiency is the operative word. The DoC asserts compliance with every applicable principle, so each assertion needs a document that would still support it if the assertion were challenged. A declaration of conformity with nothing behind it is not a weak document but an unsupported one.

3. Expert insights

Insight 1: the signatory is a verification point, not a formality. The person who signs must be authorised by the manufacturer and must be senior enough to represent it. CABs look at two things: whether the signatory holds a position that carries that authority, and whether the authorisation chain can be shown. Where a signature appears without a documented delegation, the document is questioned even when the underlying compliance is sound, because the framework treats the declaration as an act of the manufacturer rather than of an individual.

Insight 2: the statutory minimum and the practical document are different things. Name, address, device particulars and signatory satisfy the legal requirement. They do not satisfy a reviewer who has to judge whether the declaration is complete. Stating the EPSP relied on, listing the applicable standards and dating the issue turns the document from a bare assertion into a reference point that can be checked against the technical file. The additions cost an hour and remove an entire category of questions.

Insight 3: an overseas DoC travels with its authorisation trail. Where the manufacturer is outside Malaysia, the DoC is issued abroad and submitted through the authorised representative. The document does not become stronger or weaker in transit, but the evidence of who was entitled to sign it does become harder to establish, which is why the authorisation chain should be assembled at the same time as the DoC rather than in response to a question.

Insight 4: IVD declarations follow the same logic with different content. The template reasoning is identical, but the applicable principles differ: general EPSP for other devices and IVD-specific EPSP for IVD. An IVD declaration also has to address the specific conformity argument arising under its classification rules, so copying a general device DoC and changing the product name produces a document that is formally complete and substantively wrong.

4. Practical recommendations

• Do not sign and file. Build an evidence list behind each DoC: report number, version and date for every item relied on.
• Keep retrieval within 24 hours. A CAB question should be answerable the same working day, which is a matter of indexing rather than of effort.
• Record the EPSP version applied. State the principles relied on so that the declaration can be read against the technical file.
• Name the signatory with position. Include the office held, and retain the delegation or board authorisation that supports it.
• Align the DoC with the technical file. Device name, classification and intended use should match the registration data exactly.
• Use a separate IVD version. Do not adapt a general device DoC; start from the IVD-specific principles and classification argument.

The distinction worth holding on to is between a declaration and a summary. A summary tells the reader what has been done; a declaration commits the manufacturer to a position. The evidence list is what makes the commitment survivable, both at review and later, when a change to the device requires the declaration to be re-issued on the same foundation.

5. Verification checklist

• □ Manufacturer name and address stated in full, matching the registration data
• □ Device particulars complete, including name and classification
• □ Signatory identified with name, position and signature
• □ Authorisation for the signatory documented and retained
• □ EPSP relied on and applicable standards listed
• □ Date of issue recorded
• □ Evidence list maintained, with report number, version and date for each item

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Malaysia. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the MDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com