EU MDR 2017/745: What Importers & Distributors Need to Know (but Often Don’t)

EU MDR 2017/745: What Importers & Distributors Need to Know (but Often Don’t)

Understanding your responsibilities under MDR and why so many organisations are only discovering them now.

Over the last few years, the EU Medical Device Regulation (EU MDR 2017/745) has reshaped the responsibilities of companies handling medical devices. Much of the focus has been on manufacturers, but a growing number of organisations are now discovering, sometimes through direct contact from the HPRA, that they have legal obligations as importers or distributors under the Regulation.

For many businesses, this shift arrived quietly. Importing was historically seen as a logistics activity. Distributing products within Ireland or across the EU felt routine. MDR has changed that. These are now regulated roles with specific responsibilities that organisations must understand and demonstrate in practice.

This article explores what those responsibilities are, why they matter, and the common gaps seen across the sector, particularly among organisations that do not realise they fall under MDR at all.

Why This Matters Now

What has become increasingly clear from interactions with the Competent Authorities (HPRA within Ireland) is that many organisations have not recognised the regulatory implications of their supply chain activities. A company may believe it is simply “buying stock from a supplier in the UK” or “selling mobility products to local pharmacies,” without realising these activities place them squarely within the MDR’s scope.

And the scope is broader than many expect. Importers and distributors must now verify CE marking, review Declarations of Conformity, ensure products carry correct labelling, maintain traceability, understand storage and environmental conditions, and be alert to potential falsified devices. The HPRA’s inspections reflect this increased scrutiny, and organisations are being asked to demonstrate these checks through documented evidence.

In short: if you place a medical device on the EU or make it available on the EU market, MDR expects you to know your role and act on it. “Places on the market” means the first making available of a device (other than an investigational device) on the EU market.

For many businesses, these requirements are new, detailed, and often unexpected. Many importers are only now becoming aware that they carry direct legal accountability for device compliance when they place a medical device from outside the EU onto the union market.

Understanding your position within the medical device supply chain

While a distributor makes a device available, the importer brings it in from a third country. If a distributor buys directly from a non-EU manufacturer, they take on the legal responsibilities of an importer.

A supplier who is the first to source devices from outside the EU, place them on the Union Market, and subsequently supply them to healthcare institutions such as hospitals is both an importer and a distributor. A supplier that sources devices from an EU importer and makes them available in the Union Market is a distributor. A distributor sourcing directly from the UK post-Brexit may have unknowingly become an importer overnight.

Understanding your position within the medical device supply chain is the foundation for understanding your obligations.

What Counts as a Medical Device? (It’s Wider Than People Think)

The second major point of confusion are the requirements relating to different risk classifications of medical devices.

Under MDR, classification is based on intended purpose and associated risk. There are detailed classification rules which take into consideration several criteria including duration of contact with the human body, invasiveness, local vs systemic effect, and potential toxicity.

This means the definition stretches far beyond complex medical equipment. Practical examples include:

• walking sticks
• bed pans
• incontinence products
• contact lenses
• simple measuring devices such as 5 ml medicine spoons

Many organisations do not immediately view these items as “medical devices,” yet the MDR does and the associated importer or distributor responsibilities apply.

What Importers & Distributors Must Do: Key Responsibilities

Articles 13 (Importers) and 14 (Distributors) outline clear legal duties. These include:

1. Checking compliance before making devices available

• Is the device CE‑marked?
• Is an EU Declaration of Conformity available?
• Has a notified body been used where required?
• Is an authorised representative identified for non‑EU manufacturers?

These checks must be completed before devices are placed on the EU market.

2. Ensuring labelling and IFUs are correct

Importers are responsible for ensuring their name and address appear on the device or packaging. Distributors must verify that labelling is present, legible, and consistent with MDR requirements.

3. Maintaining full supply chain traceability

Both importers and distributors must know:

• who they sourced devices from
• who they supplied devices to

Traceability must be demonstrated through records, not verbal assurances.

4. Protecting device integrity during storage and transport

Importers and distributors must understand the importance of correct storage, transport, and environmental requirements for devices under their control, including knowledge of medical device symbols.

5. Managing complaints and serious incidents

Any complaint, even “minor” issues like packaging damage, may be relevant to MDR requirements for post-market surveillance.
Importers and distributors must:

• inform the manufacturer
• report serious incidents and concerns relating to falsified devices to the Competent Authority
• retain records of all issues raised

6. Understanding UDI and EUDAMED requirements

Importers must register on EUDAMED and understand UDI’s role in traceability.
Many organisations are unaware of these obligations or have only recently begun preparing for them.

What Authorities Are Finding During Inspections

From Anne Marie’s work supporting organisations through HPRA interactions, several themes consistently appear:

• Companies are unaware that the products they place or make available on the market are medical devices.
• Lack of awareness of their regulatory requirement under the MDR and limited detail within company procedures
• Devices under their control which do not comply with MDR requirements.
• Companies could not provide evidence of verification checks, having a register of non-conforming devices and a register of customer complaints.
• Lack of awareness of reporting requirements to other stakeholders, including manufacturers, authorised representatives and competent authorities for complaints, serious risks or falsified devices.
• Weak or incomplete traceability records

These issues are common and avoidable with the right awareness and internal processes.

Common Misconceptions That Lead to Non‑Compliance

Some of the most frequent misconceptions include:

• “We don’t import anything; we just buy from the UK.”
• “It’s just a consumer product, not a medical device.”
• “The manufacturer handles compliance; we just move the product from A to B”
• “Traceability is only for manufacturers.”

Each of these assumptions creates risk, because under MDR the responsibilities of importers and distributors are explicit and non‑negotiable.

Strengthening Compliance: Practical First Steps

Organisations looking to build MDR compliance should start with:

1. Identifying their role(s) clearly (importer, distributor, or both).
2. Understanding which products are medical devices and knowing their risk classification.
3. Reviewing documentation flow (DoCs, CE certificates, IFUs).
4. Checking labels for correct importer and manufacturer details.
5. Mapping supply chain traceability.
6. Understanding & reviewing storage and transport conditions.
7. Training procurement, warehouse and quality teams, not just management.

Small steps in awareness often deliver the biggest reduction in risk.

Where Training Helps

Because these responsibilities are new to many organisations, focused training helps teams understand what MDR expects in practice.
SQT’s EU MDR Importers & Distributors Programme is built around real‑world examples, labels, IFUs, Declarations of Conformity, and the types of issues found during HPRA inspections to help organisations develop clarity and confidence in meeting their obligations.

If you need support understanding your responsibilities or mapping your current processes, this programme provides a structured, practical starting point.

Conclusion, Understanding Your Role Under MDR

One of the biggest risks organisations face today is not knowing they are importers or distributors under MDR. Once you understand your role, the responsibilities become clearer and far more manageable.

By taking time to understand the requirements now, organisations can protect themselves, their customers, and the safety and performance of the medical devices under their con