14 Aug Placing on the market vs making available on the market
“Placing on the market” vs “Making available on the market”
The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) make important distinctions between ‘making available on the market’ and ‘placing on the market’ for medical devices and IVDs. Understanding these concepts is crucial for manufacturers and economic operators to ensure compliance.
Placing on the Market:
MDR Article 2(28) and IVDR Article 2(21) define ‘placing on the market’ as “the first making available of a device, other than an investigational device, on the Union market.” This refers specifically to the initial introduction of an individual device to the EU market.
Making Available on the Market:
According to MDR Article 2(27) and IVDR Article 2(20), ‘making available on the market’ means “any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.” This broad definition covers any supply of a device within the EU market after its initial introduction.
Key Differences:
1. Timing: ‘Placing on the market’ occurs only once – when a device is first made available. ‘Making available’ can occur multiple times throughout a device’s lifecycle.
2. Compliance requirements: Devices must fully comply with MDR/IVDR requirements at the time of ‘placing on the market’. Subsequent ‘making available’ does not require re-assessment of compliance.
3. Responsibility: Manufacturers and importers are primarily responsible for ‘placing on the market’, while distributors are typically involved in subsequent ‘making available’.
4. Scope: ‘Placing on the market’ applies to each individual device, not just device types.
Understanding these distinctions is essential for economic operators to fulfill their obligations under the MDR and IVDR, ensuring the safety and compliance of medical devices in the EU market.
For non-EU-based Manufacturers
The distinction between ‘placing on the market’ and ‘making available on the market’ has important implications for none EU-based medical device companies selling their product in the European market under EU regulations:
Placing on the market:
– This refers to the first time the device is made available on the EU market.
– For a none EU-based company, this typically occurs when they first transfer ownership of the device to an EU-based importer or distributor.
– The device must fully comply with all applicable EU MDR requirements at this point.
– The non-EU manufacturer is responsible for ensuring compliance before placing the device on the market.
Making available on the market:
– This refers to any subsequent distribution or supply of the device within the EU market after it has been placed on the market.
– For the non-EU company, this usually involves their EU-based partners (importers, distributors) supplying the device to end users or other economic operators.
Key implications:
1. Compliance timing: The non-EU company must ensure their device meets all EU MDR/IVDR requirements before it is first placed on the market by their EU importer/distributor.
2. Responsibilities:
– The non-EU manufacturer is primarily responsible for the initial ‘placing on the market’ and must fulfill all manufacturer obligations under the MDR/IVDR.
– EU-based importers and distributors are responsible for subsequent ‘making available’ activities and have their own set of obligations under Articles 13 and 14 of the MDR.
3. Authorized Representative: The non-EU company must designate an EU Authorized Representative to fulfill certain regulatory obligations on its behalf within the EU.
4. Documentation: The non-EU company must provide an EU Declaration of Conformity and technical documentation to their EU partners for the initial placing on the market.
5. Post-market surveillance: The non-EU company must have systems in place to monitor the performance of their device once it’s placed on the EU market and made available to end users.
6. Traceability: The non-EU company must implement UDI systems to ensure the traceability of their devices throughout the supply chain in the EU.
Conclusion
Understanding these distinctions is essential for economic operators to fulfill their obligations under the MDR and IVDR, ensuring the safety and compliance of medical devices in the EU market.
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