EU Authorized Representative for Bangladesh: Dressings, Gowns and the Rule 4 Problem

A wording on the carton decides the class

Bangladesh's medical device exports grow out of its textile and garment base: gauze swabs, bandages and wound dressings, surgical gowns, drapes, caps and masks. European law does not treat that as one category. Annex VIII of the Regulation splits it by what the product is intended to do, and the split is decided by the manufacturer's own claim:

"All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:" (MDR Annex VIII, Chapter III, Rule 4)

The lowest of those is written into the Regulation like this:

"class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;" (MDR Annex VIII, Chapter III, Rule 4, first indent)

Which means that a marketing line drafted for a hospital buyer in Dhaka — promotes healing, maintains a moist wound environment, treats deep wounds — is not marketing at all once the carton crosses into the Union. It is a classification decision, and it can move the same gauze from a self-declared product to one requiring a certificate. Fix the intended purpose wording before anything else in the file.

Sterile presentation is not a packaging choice

Bangladeshi manufacturers increasingly supply gowns, drapes and dressings sterile, because that is what European hospital tenders ask for. Sterility changes the conformity assessment route regardless of the Rule 4 outcome. A class I device placed on the market in sterile condition becomes class Is, and Article 52(7) draws in a notified body with a defined scope:

"in the case of devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions;" (MDR Art. 52(7)(a))

The assessment is limited to sterility, which is narrower than a full class IIa route, but it still means an application, an audit of the relevant processes, a certificate, ongoing surveillance and the notified body's identification number after the CE marking. Sterilisation validation, bioburden monitoring, packaging integrity and shelf-life evidence all become auditable records rather than supplier assurances.

The old CE certificate in the drawer

This is the conversation we have most often with Bangladeshi manufacturers, and it needs to be had honestly. A firm holds a certificate or a declaration of conformity issued in the Directive era and assumes it still carries the product. Three different situations hide behind that assumption.

1. A product self-declared as class I under Directive 93/42/EEC and still class I under the Regulation: no transitional extension ever applied, because there was no notified body certificate to extend. Compliance with the Regulation was required from the date it began to apply.
2. A product with a valid notified body certificate under Directive 93/42/EEC: Article 120 of the Regulation, as amended by Regulation (EU) 2023/607, allows continued placing on the market until 31 December 2027 for class III and class IIb implantable devices, and until 31 December 2028 for other class IIb, class IIa, and class I devices placed on the market in sterile condition or having a measuring function — but only where the conditions in Article 120(3c) were met. Those conditions include a quality management system compliant with Article 10(9) in place no later than 26 May 2024, a formal application lodged with a notified body no later than 26 May 2024, and a signed written agreement no later than 26 September 2024.
3. A product self-declared under the Directive that the Regulation up-classifies. That case has its own paragraph.

"Devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until 31 December 2028." (MDR Art. 120(3b), as inserted by Regulation (EU) 2023/607)

Those application deadlines have passed. If your company did not lodge an application and sign an agreement with a notified body within them, the extension is not available and the product needs a conformity assessment under the Regulation on its own terms. That is uncomfortable, and it is far better discovered in a planning meeting than at a border.

What DGDA registration establishes

The Directorate General of Drug Administration is Bangladesh's national regulator for medicines and medical devices, and it publishes its own medical device registration guidance and maintains registers of the devices it has authorised. Registration with DGDA is authorisation for the Bangladeshi market.

It makes no finding against the general safety and performance requirements in Annex I of the Regulation, produces no EU declaration of conformity, and generates no certificate a notified body can rely on. Where DGDA has relied on approvals granted abroad, that reliance runs inward, into Bangladesh; it creates no reciprocal recognition running outward.

Questions a textile-derived file has never been asked

The evidence a European buyer asks for and the evidence Annex II asks for overlap only partly. Across dressings, gowns and drapes the gaps are consistent:

• Biological evaluation for contact with intact skin, injured skin or mucous membrane, matched to the actual contact duration.
• Chemical characterisation of what the textile chain leaves behind: bleaching residues, sizing and finishing agents, dyes, adhesives and release liners.
• Sterilisation validation with a stated method, dose or cycle, and routine control, plus a bioburden programme upstream of it.
• Sterile barrier system validation, shelf life and transport testing, with real data rather than an assumed two years.
• A clinical evaluation, proportionate to the class, that survives contact with Annex XIV.
• Batch traceability that reaches down to the UDI carrier on the sales packaging.

Getting the mandate, the registration and the labels right

Article 11 of the Regulation requires a manufacturer established outside the Union to designate a sole authorised representative before its devices may be placed on the Union market, and the designation is only valid once accepted in writing. From there the practical steps are the single registration number, the actor and device entries in EUDAMED, a named importer, and labels and instructions for use in the official Union languages each destination Member State requires. Medex holds EUDAMED authorised representative SRN TR-AR-000057550 and keeps a person responsible for regulatory compliance in-house with a deputy. The task list that comes with the mandate is on our EU Authorized Representative page, and the registration workflow on our EUDAMED registration page.

What Dhaka and Gazipur manufacturers ask

Our gauze is class I. Do we still need an EU Authorized Representative?

Yes. The requirement in Article 11 attaches to being a manufacturer established outside the Union, not to the risk class. A class I non-sterile dressing self-declares its conformity and still needs a designated representative, an importer and EUDAMED registration before it can be placed on the market.

We hold a CE certificate issued under the old Directive. Is it still valid?

Possibly not. Certificates issued under Directive 93/42/EEC were extended by Regulation (EU) 2023/607 only where the conditions in Article 120(3c) were satisfied, including a formal application to a notified body by 26 May 2024 and a signed agreement by 26 September 2024. Send us the certificate and we will tell you which of the three situations above applies.

We supply sterile surgical gowns. What exactly will the notified body look at?

Only the aspects relating to establishing, securing and maintaining sterile conditions, if the product is otherwise class I. In practice that means your sterilisation process, its validation, bioburden control, packaging and shelf life, and the quality system elements that hold them together. The clinical and design content stays your responsibility to document but is not the subject of that certificate.

Our European buyer says it will handle the registration. Is that enough?

Only if the buyer is genuinely the manufacturer, meaning the device carries its name and it accepts the obligations that come with it. If your name is on the product, you are the manufacturer, and a buyer cannot register on your behalf as a substitute for designating a representative. Send us the label artwork if you are not sure which of you is which.