Can a notified body use our audit reports?
It can consider them as input. It cannot rely on them in place of its own assessment under Annex IX.
Canada, Japan, Australia, Brazil
One audit, five regulators, and still no route into the European Union
Manufacturers in Canada, Japan, Australia and Brazil arrive with a well-run quality system audited under a single programme, and reasonably ask why Europe wants another audit. The answer is not about quality. It is about who is party to the programme.
What the audit is accepted for
Acceptance follows membership, and membership has been widening.
| Authority | Position | Practical effect |
|---|---|---|
| Health Canada | Participating | A certificate is required for a medical device licence |
| FDA | Participating | Reports substitute for routine surveillance inspections, with defined exceptions |
| TGA, Australia | Participating, and now hosting programme governance | Accepted as evidence of quality system conformity |
| PMDA and MHLW, Japan | Participating | Accepted within the Japanese quality system route |
| ANVISA, Brazil | Participating | Accepted in place of a separate inspection |
| Malaysia, South Africa | Affiliate members | Reports and certificates accepted as evidence of quality system compliance |
| European Union | Not a participating authority | No MDR certificate results from the audit |
Why the European assessment cannot be replaced
Under the MDR, a notified body designated for the relevant device codes assesses the quality system against Annex IX and, for most classes, the technical documentation as well. That assessment is the legal basis of the certificate, and it is tied to the designation of the body performing it. No audit carried out under another programme can produce it.
This does not make the existing audit worthless for the European file. A mature system audited against ISO 13485 covers a large part of what Annex IX examines, and the audit history is evidence of a functioning system. The work that remains sits mostly in the technical documentation, the clinical evaluation and the post-market processes the Regulation names.
The 2026 revision changes the starting point, not the destination
The revised audit approach issued in February 2026 aligns the model directly with ISO 13485 and the FDA quality management system regulation, drops the legacy references to the old Part 820 sections and adds criteria for predetermined change control plans in devices using artificial intelligence. Governance of the programme has moved to the Australian authority.
For a manufacturer looking at Europe, the useful consequence is that the audited system now speaks the same standard the European route starts from. The gap is narrower than it was two years ago and it is still a gap that only a designated body can close.
Questions from quality and regulatory teams
Do we need a separate quality system for Europe?
No. One system, extended with the processes the Regulation requires: person responsible for regulatory compliance, post-market surveillance planning, periodic safety update reporting, post-market clinical follow-up and vigilance on the European timelines.
We are in Canada and already licensed. What is genuinely new in Europe?
Classification under Annex VIII, technical documentation to Annexes II and III, clinical evaluation under Article 61, registration in EUDAMED and a sole authorised representative established in the Union.
Does the programme help with the representative requirement?
Not at all. That obligation follows from Article 11 MDR and applies to any manufacturer without a registered place of business in a Member State.
Official basis checked on 15 August 2026
The MDR requirements described on this page were checked against the EUR-Lex text. The programme membership is described as published by the MDSAP participating authorities.
Regulation (EU) 2017/745 (MDR) in EUR-Lex → · FDA: Medical Device Single Audit Program →
Plan the EU route
Map the work before committing to a certification timeline.
Review the service scope for manufacturers established outside the Union, or start with the market entry hub to see the route end to end.