EU Authorized Representative for Pakistan: Sialkot Instruments and MDR Class Ir

Pakistan's largest device export is the one the Regulation singles out

Sialkot makes surgical instruments. Forceps, scissors, retractors, needle holders, clamps, dental extraction instruments, veterinary instruments — stainless steel, reusable, sold worldwide, and produced by hundreds of firms of every size. It is the defining fact of Pakistan's medical device sector, and it is also the reason a Pakistani exporter's route into Europe is unlike almost anyone else's.

Reusable surgical instruments have their own carve-out in MDR Annex VIII. Rule 6 puts surgically invasive devices intended for transient use in class IIa, and then names an exception: reusable surgical instruments are classified as class I. That reads like good news. Article 52 then takes part of it back, and the part it takes back is the whole substance of the file.

Class Ir: the class that looks self-declared and is not

Class I devices are ordinarily declared conformant by the manufacturer alone. Three sub-categories break that pattern, and reusable surgical instruments are one of them. The Regulation is explicit about how far the notified body's involvement runs:

"in the case of reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use." (MDR Art. 52(7)(c))

So the device is class I, and there is still a notified body, a certificate, an audit, surveillance, and an identification number printed after the CE marking under Article 20(5). The scope is narrow but the machinery is real. Whether an instrument falls inside the definition is settled in Annex VIII itself:

"‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out." (MDR Annex VIII, Chapter I, Section 2.3)

Note the exclusion for anything connected to an active device. A powered or electrosurgical handpiece is not a reusable surgical instrument in this sense, and is classified by whichever other rule applies — usually considerably higher.

What DRAP issues, and how far it travels

Pakistan regulates devices under the Medical Devices Rules, 2017, notified by the Drug Regulatory Authority of Pakistan as S.R.O. 32(I)/2018 on 16 January 2018. An establishment applies for a manufacturing licence on Form-1 or an import licence on Form-2, and the licence itself issues on Form-3 or Form-4, valid for five years. Devices are then listed: Class A products are enlisted on Form-6 or Form-6A, while Class B, C and D products are registered on Form-7 or Form-7A. Rule 27(2) requires a valid establishment licence and an enlisted or registered device before export.

DRAP grades hazard in Schedule A as Class A low, Class B low-moderate, Class C moderate-high and Class D high. Most Sialkot instruments sit in Class A, which is the lightest route Pakistan offers — enlistment rather than a registration dossier. That is precisely the point at which European law becomes heavier rather than lighter. The Pakistani and European systems are at their most divergent exactly where Pakistan's export volume is concentrated.

Instrument by instrument, where each product lands

The reprocessing file that decides how the audit goes

Article 52(7)(c) names the aspects the notified body will look at, and it is worth reading them as an audit agenda rather than as legal text. Cleaning and disinfection methods have to be validated, not asserted. Sterilization instructions have to be ones a European hospital sterile services department can actually execute with the equipment it has. Maintenance covers sharpening, joint articulation, insulation where relevant, and the point at which an instrument should be withdrawn. Functional testing means demonstrating that the instrument still performs after reprocessing, not merely that it still exists.

What Sialkot technical files usually contain instead is material certification, passivation and finishing records, dimensional inspection and corrosion testing. All of that is necessary and none of it is the reprocessing evidence the Regulation asks for. Building the missing part is the single largest piece of work in a Pakistani MDR project, and it should be started before a notified body is approached rather than after.

Whose brand, and therefore whose obligation

A large share of Sialkot output leaves the country unbranded or under a European customer's mark. Where the finished instrument, its packaging and its instructions for use carry only the customer's name, that customer is the manufacturer under the Regulation and carries the obligations, including the technical documentation and the reprocessing evidence — which it will obtain from you by contract even though the legal duty is its own.

Where your own mark appears anywhere on the product, the packaging or the leaflet, your Pakistani company is the manufacturer, and Article 11 requires the designation of a sole authorised representative established in the Union before the device may be placed on the market. Many Sialkot firms now run both models at once, which means both analyses have to be done product by product rather than company-wide.

Appointing a representative and getting registered

The designation is a written mandate accepted by both sides and effective for at least all devices of the same generic device group. It carries a defined list of tasks: keeping the technical documentation available to competent authorities, handling their requests in the language they specify, cooperating on corrective action, and registering the actors and devices in EUDAMED. Medex acts under EUDAMED single registration number TR-AR-000057550, keeps a person responsible for regulatory compliance in-house with a named deputy, and works from Ankara, Istanbul and Gdańsk. Annual fees are class-based and published on pricing; the task list is set out on the EU Authorized Representative page.

Sialkot exporters: what comes up at the first meeting

Our instruments are class I. Why is a notified body involved at all?

Because class I splits. Sterile presentation, a measuring function and reusable surgical instruments each pull a notified body into the conformity assessment, with the scope limited to that attribute. Your instrument is genuinely class I and it still needs a certificate covering reprocessing before it can be placed on the Union market.

We are enlisted with DRAP on Form-6. Does that shorten anything in Europe?

It does not shorten the conformity assessment. DRAP enlistment records a Class A device against a licensed establishment under Pakistani law; it involves no assessment against Annex I of the Regulation and produces no document a notified body can rely on. It is useful evidence of manufacturing control and nothing more.

We supply instruments unbranded to a German company. Do we still need a representative?

Not for those products. If the German company's name is the only one on the device, its packaging and its instructions for use, it is the manufacturer and the obligations are its own. You will still be asked to supply design, material and reprocessing evidence into its technical documentation, and it is worth agreeing in the supply contract what that includes.

We sell both reusable and sterile single-use instruments. Is one certificate enough?

No. The two attributes have different notified body scopes, and a single-use surgical instrument loses the reusable exception in Rule 6 altogether, which usually places it in class IIa with a full assessment. Split the catalogue before you apply. Send us the product list and we will do the split with you.