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How One Egyptian Exporter Passed EU MDR Audit for Class I Devices

Executive Snapshot

An Egyptian medical device exporter faced a significant hurdle: passing the EU MDR (Medical Device Regulation) audit to continue selling its Class I devices in the European Union. With limited regulatory experience and outdated documentation, the company risked losing access to its most profitable market. Through strategic document restructuring, gap analysis, and a guided compliance process, the exporter passed the audit successfully, maintaining its EU distribution and gaining new European clients.

Background / The Situation

The client, a mid-sized Egyptian manufacturer of Class I disposable medical devices (such as surgical gloves and bandages), had been exporting to the European Union under the previous MDD framework. Following the full enforcement of the EU MDR in 2021, the company received notice from its distributors that they would require updated declarations and technical documentation to maintain CE-marked sales.

While the products were low-risk (Class I), the new EU MDR introduced stricter requirements around documentation, post-market surveillance, and supplier controls. The client had no in-house regulatory affairs officer and minimal knowledge of EU legal language. With shipments on hold and revenue in jeopardy, the company urgently needed to pass the MDR audit by a notified body.

The Problem

The exporter’s existing compliance documentation was insufficient:

The Technical File lacked a clear risk classification rationale.
The Declaration of Conformity hadn’t been updated since 2018.
No documented procedure for post-market surveillance (PMS).
The supplier agreement template lacked MDR-mandated quality clauses.

Without immediate legal and regulatory assistance, the company faced:

Suspension of exports to EU clients.
Contract terminations with EU distributors.
Long-term reputational damage within the industry.

The urgency of the audit, combined with low internal capacity, created an environment where a misstep could result in losing their foothold in the European market.

The Strategy or Solution

1. Legal & Regulatory Gap Analysis

We started by comparing the client’s current documents against MDR Annexes I, II, and III. Using a custom checklist, we flagged missing elements, such as:

UDI (Unique Device Identifier) policy references
Confirmation of risk classification according to Rule 1
PMS and Vigilance Procedures

2. Updating Core Legal Documents

We rewrote and restructured several key documents:

Technical File: Clearly categorized the product as Class I under Rule 1, with basic design description, labeling, and validation.
Declaration of Conformity: Reissued to reflect MDR compliance, referencing Regulation (EU) 2017/745.
PMS Procedure: Created a streamlined, proportional surveillance procedure tailored for low-risk Class I devices.

3. Distributor and Supplier Alignment

We reviewed and amended:

Distribution Agreements: Added clauses requiring distributors to inform the manufacturer of complaints and incidents.
Supplier Contracts: Added quality assurance and traceability requirements to align with MDR expectations.

4. Client Training and Mock Audit

We trained the quality manager and CEO on:

Key audit questions
Role of the PRRC (Person Responsible for Regulatory Compliance)
Document presentation order

We then ran a mock audit session to simulate the interaction with the notified body.

The Outcome

Within 21 business days of the engagement, the Egyptian company passed the MDR Class I audit. The notified body praised the clarity and simplicity of the documentation.

Results:

CE Mark maintained without disruption
New contract signed with a French distributor
Internal SOPs improved to match EU best practices

Key Takeaways

Even Class I devices need serious documentation under EU MDR. Don’t assume simplicity equals low risk.
Tailored legal updates can dramatically reduce audit risk. You don’t need a full legal department—just the right guidance.
Distributor contracts must be MDR-aligned. The EU compliance chain includes your partners.

Call-to-Action

If you’re a non-EU medical device manufacturer preparing for an MDR audit, start with your legal documents. Need a customized checklist or help reviewing your tech file? Book a consultation