Article 5 of the MDR is the gateway provision. It states the fundamental rule: a device may be placed on the market or put into service only if it complies with the MDR when duly supplied and properly installed, maintained, and used in accordance with its intended purpose .

This sounds straightforward, but the implications for startups are substantial. Article 5 establishes the legal preconditions for everything you do as a manufacturer. Here is what it means in practice.

What Does "Placing on the Market" Mean?

Article 2(28) defines "placing on the market" as the first making available of a device, other than an investigational device, on the Union market. This is a one-time event for each individual device unit — the moment it first enters the EU distribution chain.

For a startup, placing on the market happens when you first supply your device for distribution, consumption, or use on the EU market in the course of a commercial activity. This includes: - Selling to a distributor - Selling directly to a hospital or clinic - Selling directly to a patient (for consumer devices) - Providing the device free of charge in a commercial context (e.g., free trials that are part of a sales strategy)

It does not include: - Manufacturing a device that stays in your warehouse - Transferring devices between your own facilities - Providing devices for clinical investigations (these are "investigational devices" with separate rules) - Exhibiting at trade shows (with proper disclaimers that the device is not for sale)

What Must Be True Before You Place a Device on the Market?

Article 5 creates a comprehensive set of preconditions. Before you can legally place your device on the EU market:

1. The device must conform to the MDR. This means full compliance with: - The applicable General Safety and Performance Requirements (Annex I) - The applicable conformity assessment procedure - All labeling and information requirements - All registration and UDI requirements

2. The conformity assessment must be completed. For devices requiring Notified Body involvement, this means you must have received the relevant certificates. For Class I devices (non-sterile, non-measuring), this means you must have completed the self-assessment procedure per Annex IX Chapter I or the applicable conformity assessment route.

3. The EU Declaration of Conformity must be drawn up. Article 19 requires the manufacturer to draw up an EU declaration of conformity per Annex IV . This declaration is a formal legal document stating that the device conforms to the MDR.

4. The CE marking must be affixed. Article 20 requires the CE marking to be affixed to the device before placing on the market . The CE marking must be visible, legible, and indelible, and follow the format prescribed in Annex V.

5. The manufacturer must be registered. Article 31 requires manufacturers to register in the electronic system (EUDAMED or the relevant national system) before placing a device on the market .

6. The device must be registered. The device itself must be registered with its UDI in the electronic system.

7. The manufacturer must be established in the EU or have an authorized representative. If your manufacturing entity is outside the EU, you must designate an authorized representative in the EU before placing devices on the market (Article 11) .

What Does "Putting into Service" Mean?

Article 2(29) defines "putting into service" as the stage at which a device has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.

For many devices, placing on the market and putting into service happen simultaneously — for example, when you sell a consumer medical device directly to a patient. But for devices that require installation, calibration, or professional setup, putting into service occurs later, when the device is actually ready for use.

The MDR requires compliance at the point of putting into service, not just at the point of placing on the market. This means any installation, configuration, or setup that you or your authorized service provider performs must maintain the device's conformity with the MDR.

What Are the Specific Conditions Article 5 Sets Out?

Article 5 has multiple paragraphs addressing different scenarios:

Article 5(1): The basic rule — a device may be placed on the market or put into service only if it complies with the MDR.

Article 5(2): Devices must meet the requirements of the MDR that are applicable at the time of placing on the market or putting into service .

Article 5(3): Addresses devices that are only partly completed, or that are intended to undergo further processing before use. These must comply with the applicable MDR provisions.

Article 5(5): Sets conditions for making devices available at trade fairs, exhibitions, and similar events — the device must bear a visible sign clearly indicating that it cannot be put into service until it is brought into conformity with the MDR .

How Does Article 5 Affect Your Launch Plan?

For a startup planning market entry, Article 5 creates a clear checklist:

Before launch, you must have: - [ ] Completed conformity assessment (Notified Body certificates if applicable) - [ ] Drawn up the EU Declaration of Conformity - [ ] Affixed the CE marking - [ ] Registered yourself as manufacturer - [ ] Registered your device with UDI - [ ] Appointed an authorized representative (if you are outside the EU) - [ ] Ensured labeling compliance (label, IFU, packaging) - [ ] Implemented your post-market surveillance system - [ ] Implemented your vigilance system - [ ] Assigned a Person Responsible for Regulatory Compliance (Article 15)

This is not a suggested best practice list. This is the legal minimum for placing a device on the EU market. Missing any item means your device is non-compliant under Article 5.

What Happens If You Place a Non-Compliant Device on the Market?

The consequences are defined throughout the MDR:

Market surveillance action. Competent authorities can restrict or prohibit the device's availability, require a recall, or require a field safety corrective action.

Notified Body consequences. If your Notified Body becomes aware of non-compliance, they can suspend or withdraw your certificate.

Penalties. Member states define penalties for MDR infringements (Article 113). These can include substantial fines and, in cases involving patient harm, criminal sanctions.

Liability. Under the EU Product Liability Directive, the manufacturer is liable for damage caused by a defective product. A device that does not conform to the MDR is not automatically "defective" in the product liability sense, but non-compliance with safety requirements is strong evidence of defectiveness.

Reputational damage. In the MedTech industry, news of regulatory non-compliance travels fast. For a startup building credibility with hospitals, clinicians, and investors, a market surveillance action can be devastating.

Article 5 and the Startup Mindset

From a business perspective, Article 5 can feel like a barrier. Every item on the checklist costs time and money, and for a startup racing to generate revenue, the temptation to cut corners is real.

Let me be honest: this is simply not possible. The MDR is not optional, and the enforcement mechanisms are real. But the checklist is also not as overwhelming as it appears when you see it for the first time. Each item is a defined, achievable requirement. When you plan for them from the beginning — when you build your product development process around the MDR rather than treating compliance as an afterthought — the Article 5 requirements become milestones in your project plan, not roadblocks at the end.

The startups that struggle with Article 5 are those that develop their product first and then discover what the MDR requires. The startups that succeed are those that know the Article 5 checklist before they write a line of code or produce a prototype.

Next: What Is a Manufacturer Under MDR Article 2(30)? Legal Obligations for Startup Founders.