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EU Authorized Representative for Bahrain: NHRA Approval and the MDR Mandate

Bahrain has one health regulator, the National Health Regulatory Authority, with a Medical Devices and Supplies Control Section of its own. The European Union has a competent authority in every Member State and notified bodies for conformity assessment, and it recognises no NHRA approval. For a Bahraini manufacturer the piece that ties the European side together is the sole authorized representative required by Article 11(1) of Regulation (EU) 2017/745: the Regulation routes competent-authority contact through it and treats the representative's Member State as the manufacturer's. This page covers the mandate, the file we hold, Bahraini documents abroad (Bahrain is an Apostille Convention party), the Article 12 handover from an existing representative, and why one mandate with Medex in Türkiye covers the Union and Türkiye.

NHRA in Manama: one authority for facilities, professionals and devices

Bahrain regulates healthcare through the National Health Regulatory Authority, NHRA (nhra.bh), which describes itself as an independent regulatory body established in 2010 under Law No. 38 of 2009 to regulate the provision of healthcare in Bahrain. Its organisation includes a Medical Devices and Supplies Control Section alongside the Pharmacy and Pharmaceutical Products Regulation Section, and its e-services portal carries a Medical Devices Application. A Bahraini manufacturer or brand owner therefore has a single, device-aware regulator at home.

The Union has many. Regulation (EU) 2017/745 is applied by the competent authority of each Member State, with conformity assessment delegated to notified bodies. There is no single European approval to apply for, and there is no route by which an NHRA approval is recognised. What ties the European side together for a third-country manufacturer is the representative, because the Regulation routes competent-authority contact through it.

The representative as the competent authorities' address

"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."

Regulation (EU) 2017/745, Article 11(1).

"Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business."

Regulation (EU) 2017/745, Article 11(7).

A Bahraini manufacturer's "home" competent authority in Europe is therefore defined by where its representative sits.

Where Medex sits, and why that is inside the Union market

"The ’Union market’ refers to the territories of the European Union Member States, and due to the European Economic Area (EEA) is extended to Norway, Lichtenstein and Iceland, and via the Customs Union Agreement to Turkey."

MDCG 2022-16, footnote 1.

Medex is established in Ankara and holds EUDAMED authorized representative single registration number TR-AR-000057550. A mandate with Medex covers the Union and Türkiye for the generic device group it names. Where devices are also sold in Türkiye, the Turkish importer registers them in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system; we handle that for importers under a separate contract, described under Türkiye market access.

Tasks in the mandate

Article 11(3) sets the minimum content of the mandate. The two tasks that define the day-to-day relationship with a Bahraini manufacturer are holding the file and answering authorities:

"keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);"

Regulation (EU) 2017/745, Article 11(3)(b).

"in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;"

Regulation (EU) 2017/745, Article 11(3)(d).

NHRA works in Arabic and English. For point (d) the practical choice is English throughout: declaration of conformity, labelling, instructions for use and the core of the technical documentation.

Bahraini documents in the Union and in Türkiye

DocumentTreatment
MandateValid on written acceptance by the representative (Article 11(2)). No Apostille, no legalisation.
EU declaration of conformity, technical documentationPrivate documents of the manufacturer; held by us under Article 11(3)(b).
Bahraini corporate or signatory document used before a Turkish authorityApostille issued in Bahrain. The HCCH status table records Bahrain's accession on 10-IV-2013 and entry into force on 31-XII-2013. A sworn Turkish translation is added.
LabelCarries our name and registered place of business under Annex I, Section 23.2(d), next to yours under 23.2(c).

Moving an existing mandate to Medex

"The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative."

Regulation (EU) 2017/745, Article 12.

If a Bahraini manufacturer already has a representative elsewhere in the Union and wants to consolidate the Union and Turkish sides, the Article 12 agreement is the instrument. The pricing page lists "Change of representative: EUR 150. Article 12 handover." and states: "We draft and run that agreement as part of the EUR 150." The procedure is described under how to change EU authorized representative.

Registration data and its upkeep

"Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation."

Regulation (EU) 2017/745, Article 31(5).

Both actors confirm their data on that cycle. We run it for our own record and track yours; see EUDAMED registration.

Medex is an authorized representative under Article 11 and nothing else in the chain. We are not a notified body: a notified body is, in the words of Article 2(42), "‘notified body’ means a conformity assessment body designated in accordance with this Regulation;" and only such a body can issue the certificate a class IIa, IIb or III device needs. We are not your importer or distributor either; the importer is the Union entity that physically places your consignment on the market, and that role carries its own duties under Article 13.

Fees are listed on our pricing page: "Fees from EUR 800 a year, no setup fee, one mandate." and "Fees are in euros, exclude VAT, and are fixed for three years from signature."

Gulf pages: Saudi Arabia, Kuwait and Qatar.

Frequently asked questions

We have an NHRA medical device approval. Does it count in the European Union?

No. NHRA approval authorises the Bahraini market. Regulation (EU) 2017/745 does not recognise third-country approvals. Conformity is shown through technical documentation and, above class I, a notified body certificate.

Is NHRA the equivalent of a notified body?

No. NHRA is Bahrain's health regulator, established under Law No. 38 of 2009. A notified body is a conformity assessment body designated under the Regulation by a Member State, and only such a body issues the certificate a class IIa, IIb or III device needs.

Can we change from our current representative to Medex?

Yes. Article 12 requires an agreement between the manufacturer, the outgoing representative where practicable, and the incoming one, covering the dates, the transfer of documents and the handling of complaints. The pricing page lists the handover at EUR 150.

Does an Apostille from Bahrain work in Türkiye?

Yes. Bahrain is a Contracting Party to the Apostille Convention, so a Bahraini public document with an Apostille is accepted in Türkiye without consular legalisation, with a sworn Turkish translation added. The mandate itself needs no Apostille.

Does one mandate cover the European Union and Türkiye?

Yes. MDCG 2022-16 states that the Union market extends to Türkiye via the Customs Union Agreement. One mandate with a representative established in Türkiye covers both for the generic device group it names.

Send us your NHRA device approval references, the name on the label and any existing mandate, and we will return either a new mandate draft or the Article 12 handover agreement. Request a proposal.

Sources and further reading

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