EU Authorized Representative for the Philippines: From an FDA CMDR to MDR Annex II

Class A to D in Manila, class I to III in the Union: the letters do not map

Department of Health Administrative Order No. 2018-0002 of 26 January 2018, "Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements", aligned Philippine registration with the ASEAN Medical Device Directive (AMDD). FDA Circular No. 2020-001, which began its implementation, sets out the four AMDD risk classes: A (low), B (low-moderate), C (moderate-high) and D (high). Devices not on the FDA's list are classified using the AMDD rules as referenced in AO 2018-0002.

The Union uses a different scale and a different rulebook:

"Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII." (MDR Article 51(1))

It is tempting to read A as I and D as III and fill in the middle. That shortcut fails in both directions. Annex VIII has twenty-two rules, including rules on software, nanomaterials, substances absorbed by the body and active therapeutic devices with diagnostic functions, and it divides the middle of the risk range into IIa and IIb on criteria the AMDD letters do not track. MDR also splits class I into sub-cases that change the conformity route: sterile, measuring and reusable surgical instruments need a notified body for those aspects. In vitro diagnostics fall under a separate Regulation, (EU) 2017/746, with classes A to D of their own. Re-run the Annex VIII rules before you price a notified body.

CMDN, CMDR and what each actually authorises

FDA Circular No. 2020-001 lists the marketing authorisations the CDRRHR issues. A Certificate of Medical Device Notification (CMDN) covers class A devices. A Certificate of Medical Device Registration (CMDR) covers registrable class B, C and D devices. A Certificate of Medical Device Listing (CMDL) covers devices brought in for research, clinical trial, exhibit, personal use or donation.

Each of these is an authorisation for the Philippine market, issued by a Philippine authority, against Philippine requirements. None of them is a conformity assessment in the MDR sense, and none of them is recognised by a European notified body, competent authority or importer. A European distributor asking for your CE documentation is asking for something different in kind:

The CSDT dossier is a good start on Annex II, not a substitute

According to FDA Circular No. 2022-008, AO 2018-0002 was issued to set the documentary requirements for registration and to align them with the ASEAN Common Submission Dossier Template (CSDT), in line with the AMDD. That is a genuine advantage. A Philippine manufacturer holding a CSDT file already has a structured technical dossier in a harmonised regional format, and for classes B to D one that a regulator has examined. Many MDR projects elsewhere start from much less.

The gap is depth and structure. Annex II expects a general safety and performance requirements checklist worked against Annex I clause by clause, with the specific evidence or standard cited for each requirement. It expects full test reports rather than summaries, a clinical evaluation under Article 61 and Annex XIV, a post-market surveillance plan under Annex III, and a Basic UDI-DI for each device group. For class I products the manufacturer then declares conformity directly:

"Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III." (MDR Article 52(7))

For every other class, a notified body reviews that documentation and audits the quality system. The CSDT file shortens the work. It does not remove any part of it.

Philippine reliance runs across ASEAN, not to Brussels

The FDA has a published reliance route. FDA Circular No. 2022-008, "Abridged Processing of Application for Registration of Medical Devices Approved by the National Regulatory Authority of Any ASEAN Member Country", gives class B, C and D devices already approved by another ASEAN regulator under the AMDD-CSDT requirements an abridged evaluation with a turnaround time of thirty working days. The Circular is explicit about its limits: it "shall not cover medical devices with issued Certificate of Product Registration (CPR) based on abridged approval in other countries outside the ASEAN", and it does not cover in vitro diagnostic or refurbished devices.

Reliance is therefore regional, and it runs one way at a time. The European Union operates no equivalent route for Philippine or ASEAN approvals. A CMDR does not shorten a notified body review, and a notified body will not accept an ASEAN approval in place of its own assessment. Philippine manufacturers who have used Circular 2022-008 to move quickly between ASEAN markets should expect a full, conventional MDR procedure in Europe.

Who is the manufacturer when a Philippine plant builds for a foreign brand

Where a Philippine plant produces for another company, the first question in any European project is whose name will be on the label. MDR answers it by definition:

"a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark" (MDR Article 2(30))

If you produce to a European company's brand and that company is named as manufacturer, it carries Article 10 in full and, being established in the Union, needs no representative. You will be audited as its critical supplier. If you sell under your own brand, you are the manufacturer, and Article 11(1) applies:

"Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." (MDR Article 11(1))

The word "sole" matters. One representative covers the Union for a generic device group; you cannot appoint a different representative for each distributor.

Getting the Union side in place from Manila, Cebu or Davao

Medex Kurumsal Danışmanlık is established in Türkiye. Under the EU–Türkiye Customs Union, the European Commission's Notice to Stakeholders of March 2022 states that manufacturers established outside the territory of the EU or Turkey "only need to designate one authorised representative, either in the EU or in Turkey, in order to place medical devices on the market in the EU or in Turkey." Switzerland, Great Britain and the EEA-EFTA states are outside that arrangement and each requires a locally established representative; Medex does not act for those markets.

The steps on our side are the same for every client:

1. Written mandate under Article 11(3). It sets out the tasks the Regulation requires, starting with the first:

"verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer" (MDR Article 11(3)(a))

2. EUDAMED actor registration. Your company registers as manufacturer and receives its Single Registration Number, linked to our authorised representative SRN TR-AR-000057550.

3. UDI. Basic UDI-DI and UDI-DI data are registered for each device before it is placed on the market.

4. Person responsible for regulatory compliance. Article 15(6) requires every representative to have one permanently and continuously at its disposal. Medex's PRRC is in-house.

5. Label and IFU address. Annex I, Section 23.2(d) requires our name and registered address on the label of a device whose manufacturer is established outside the Union.

Medex works from Ankara, İstanbul and Gdańsk. We do not write technical documentation, we are not a notified body, and we do not find distributors. Annual fees are published on our pricing page, from €800 for class I to €2,000 for class III, with no setup fee and €150 for a change of representative.

Related country and guidance pages

Manufacturers in neighbouring markets face similar questions; we keep separate pages for Vietnam, Malaysia and Indonesia. The full list of countries is on the EU authorized representative by country page, and the obligations behind the mandate are set out in our EU authorized representative guide.

Frequently asked questions

We hold a CMDR from the Philippine FDA. Can it be used for CE marking?

Not as an authorisation. The CMDR permits sale in the Philippines and has no standing in the Union. The evidence behind it, including test reports, risk analysis and the CSDT dossier, can be reused as source material for MDR technical documentation, provided it was produced to recognised standards and is complete rather than summarised.

Our device is class B in the Philippines. What class will it be under MDR?

It depends on the Annex VIII rules, not on the AMDD letter. A class B device may be class I, IIa or IIb under MDR depending on invasiveness, duration of contact, whether it is active, and whether it contains software or specific substances. Classify from the intended purpose first, then check the result against MDCG guidance.

Can our European importer act as our authorized representative?

It can accept the mandate if it is established in the Union. It then becomes jointly and severally liable with you for defective devices under Article 11(5) where you have not met Article 10, in addition to its own importer duties under Article 13. Many importers decline the combined role, and it complicates any later change of distributor.

Does a Türkiye-based representative cover all EU Member States?

Yes, for the EU. The Commission's March 2022 notice confirms that manufacturers outside the EU and Turkey need only one authorised representative, either in the EU or in Turkey. It does not extend to Switzerland, Great Britain or the EEA-EFTA states, which require their own local representatives.

Sources

Food and Drug Administration Philippines — Administrative Order No. 2018-0002, Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements — www.fda.gov.ph

Food and Drug Administration Philippines — FDA Circular No. 2020-001, Initial Implementation of Administrative Order No. 2018-0002 — www.fda.gov.ph

Food and Drug Administration Philippines — FDA Circular No. 2022-008, Abridged Processing of Application for Registration of Medical Devices Approved by the National Regulatory Authority of Any ASEAN Member Country — www.fda.gov.ph

Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu

European Commission — Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu

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Related guides

Before you appoint anyone, our EU authorized representative guide explains the role and what a mandate covers, the EU authorized representative cost guide shows what the fee should include, and the buyer's checklist helps you compare providers. The contract itself is covered in our note on the mandate agreement under Article 11(3). When you are ready, you can request a proposal.

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