MDSAP to MDR: EU Authorized Representative for Canadian Medical Device Manufacturers

The part of a Canadian licence file that is already MDR-shaped

Canada is an unusual case among third countries, because a Canadian manufacturer arriving at MDR is not starting from zero on the quality side. Health Canada has required certified quality management systems for licensed devices for a long time, and since the end of the Canadian Medical Devices Conformity Assessment System it has required them through MDSAP. That is real, audited, third-party evidence. The mistake is to assume it converts. Start by separating what you hold into three buckets.

What you hold in Canada	Closest MDR counterpart	Does it carry over?
Medical Device Licence for a Class II, III or IV device	EU declaration of conformity under Art. 19 plus, above class I, a notified body certificate	No. A licence is a Canadian market authorisation with no legal effect in the Union.
Medical Device Establishment Licence	Economic operator registration under Art. 31 and the SRN	No. Different register, different obligations, different holder.
MDSAP certificate to CAN/CSA-ISO 13485	Quality management system assessed under Annex IX, Chapter I	Partly. The ISO 13485 core is recognisable; the MDR-specific layer is not covered.
Quality system documentation, procedures and records	Art. 10(9) quality management system	Largely, with additions.
Class III or IV licence application dossier	Technical documentation under Annexes II and III	Partly. Structure, GSPR mapping and clinical evaluation must be rebuilt.

Your Canadian class is not your MDR class

Both systems use four risk tiers and both use rules-based classification, which is exactly why people get this wrong. Canada classifies devices as Class I, II, III or IV under the Medical Devices Regulations (SOR/98-282), with a licence required for Classes II to IV. MDR classifies as class I, IIa, IIb and III under Annex VIII. The rule sets are not aligned and the numbering is not aligned: a Canadian Class II is not automatically an MDR class IIa, and a Canadian Class III can be an MDR class III.

The category that most often moves is software. MDR Annex VIII, Rule 11 puts software intended to provide information used to take diagnostic or therapeutic decisions in class IIa, rising to class IIb or class III according to the severity of harm a wrong decision could cause. Canadian software licensed as Class II regularly lands in MDR class IIb, which changes the conformity assessment route, the clinical evidence expectation and the cost of the project.

How far an MDSAP certificate actually travels into an Annex IX audit

MDSAP is a genuine multi-jurisdiction programme, and the list of participating regulatory authorities is the point: Australia, Brazil, Canada, Japan and the United States. The European Union is not among them, and no notified body is an MDSAP auditing organisation acting for the EU. There is no arrangement under MDR by which an MDSAP report discharges any part of a notified body's obligations.

What does carry is the underlying standard. Health Canada's requirement in sections 32(2)(f), 32(3)(j) and 32(4)(p) of SOR/98-282 is for a certificate showing the quality management system meets CAN/CSA-ISO 13485, and a system built to satisfy that will be recognisable to any notified body. Expect the auditor to accept the shape of your system and then test the parts MDSAP never assessed: the strategy for regulatory compliance, identification of applicable general safety and performance requirements, clinical evaluation under Art. 61 and Annex XIV, verification of UDI assignments under Art. 27(3), the post-market surveillance system under Art. 83, and the vigilance processes of Arts. 87 to 92.

Expect the visits too. MDR sets a surveillance rhythm that is not optional and adds one many Canadian manufacturers have never experienced: "The notified body shall randomly perform at least once every five years unannounced audits on the site of the manufacturer and, where appropriate, of the manufacturer's suppliers and/or subcontractors, which may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment." (MDR Annex IX, Section 3.4)

What a Class III licence dossier is usually missing against Annex II

Canadian licence applications are evidence-led and comparatively lean. Annex II is structured and exhaustive. The recurring gaps, in the order they tend to stall a project:

• A general safety and performance requirements checklist against Annex I, with the specific solution and the specific evidence identified for every applicable requirement, including the whole of Chapter III on information supplied with the device.
• A clinical evaluation report to Art. 61 and Annex XIV, with a clinical evaluation plan and a post-market clinical follow-up plan. Canadian safety and effectiveness evidence is often sufficient in substance and wrong in form.
• A post-market surveillance plan under Art. 84 and, for class IIa and above, periodic safety update reports under Art. 86.
• A Basic UDI-DI and UDI-DIs assigned under Art. 27, and device registration under Art. 29.
• For implantable and class III devices, a summary of safety and clinical performance under Art. 32, written for patients as well as clinicians.

Bilingual instincts do not survive contact with twenty-four languages

Canadian manufacturers are already disciplined about producing labelling and instructions in two languages, which is a real advantage in process terms: the translation controls, the review workflow and the artwork management already exist. The scale is different. Under MDR the language is determined by each Member State in which the device is made available, across the Union's official languages, and the content that must be translated is set by Annex I, Section 23 rather than by Canadian labelling requirements. A launch across Germany, France, Italy, Spain, the Netherlands and Poland is a six-language obligation decided by six competent authorities, not by you.

Appointing the representative and getting the SRN

The designation is a legal instrument, not a service agreement dressed up. MDR states: "The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group." (MDR Art. 11(2)) The last clause catches manufacturers who try to split a product family across arrangements.

Medex Kurumsal Danışmanlık holds EUDAMED SRN TR-AR-000057550 as an authorized representative, and is also registered as a manufacturer under TR-MF-000057496 and as an importer. Our person responsible for regulatory compliance is in-house, a partner of the firm, with a deputy. We work from Ankara, İstanbul and Gdańsk, and our pricing is published and class-based with annual fees from EUR 1000. See pricing and the authorized representative service, or EUDAMED registration if the actor and device modules are your immediate problem.

What Canadian regulatory managers ask us

We hold a current MDSAP certificate. Does that reduce the notified body audit?

It reduces the preparation, not the audit. A notified body assessing your system under Annex IX will recognise an ISO 13485 structure and can presume conformity for the requirements the harmonised standard covers. It has no authority to rely on an MDSAP report and will audit your premises itself, including unannounced visits at least once every five years.

Our device is Class II in Canada. Is it class IIa under MDR?

Sometimes, and it is never safe to assume. Classification must be worked through the Annex VIII rules from the intended purpose, duration of contact, invasiveness and whether the device is active. Software and reusable instruments are the two categories where the Canadian and EU answers most often diverge.

Can our Canadian entity remain the manufacturer, or does the representative take over?

You remain the manufacturer. The mandate cannot delegate the core obligations in Art. 10, and the declaration of conformity is signed by you. The representative verifies, holds documentation, registers, responds to competent authorities and cooperates on corrective action.

Do we need an importer as well as an authorized representative?

Yes, if you are shipping into the Union. The importer is a separate economic operator under MDR Art. 13 with its own registration and its own verification duties, and its details must appear on the device, its packaging or an accompanying document. Tell us your route to market at contact and we will map the operator chain before you register.