Importers – Strategic Partners

According to multiple regulations, importers of medical devices into the European marketing space must co-operate with the product manufacturers and authorised representatives to achieve an appropriate level of traceability of the devices they manage. Each economic operator connected in a medical device supply chain shall be able to check compliance of all the others involved.

Responsibilities

Importers are responsible for making sure that the devices they place on the market

  • bear CE marking,
  • are accompanied by any required information,
  • are labelled in accordance with the regulations,
  • have been assigned a UDI where applicable,
  • are registered in EUDAMED

Communications

  • If an importer considers a device is not compliant with the regulations, the importer shall not place the device on the market and the importer shall inform the manufacturer and the authorised representative of this action
  • The importer should also inform the authorities if they suspect that a device is counterfeit
  • The importer should inform the competent authority if the device poses a serious risk to public health

Labelling

Importers shall indicate on the device or its packaging, or in a document accompanying the device,

  • name, registered trade name or registered trademark,
  • registered place of business,
  • contact address

Vigilance

Importers have the responsibility to inform manufacturers and their authorised representatives in the event of complaints and escalate matters of non-compliance to the authorities

They should keep a catalogue of

  • complaints,
  • non-conforming devices,
  • recalls,
  • withdrawals from market

Importers are required to cooperate with authorities to provide device samples or grant access to the devices within their purview.

Device Handling

Importers should ensure that the storage and transport conditions do not jeopardise a device’s compliance according to the manufacturer’s instructions.

Medical Device Manufacturers

Manufacturers must be able to demonstrate control and monitoring of economic operators within the entire supply chain, which can be a regulatory compliance challenge during an audit.  This may be successfully accomplished by delineating all new responsibilities for distributors, importers, assemblers, and authorized representatives. Importers and manufacturers should pay particular attention to this issue when formulating contractual agreements.

Importers cannot execute their responsibilities unless the legal manufacturers enables them to do so by supplying the necessary documents and accurate information. Secure electronic database and data exchange solutions, on both sides, are required to ensure the correct data is transmitted to the correct entity in the correct timeframe and stored appropriately.

Manufacturers should realise championing their importers to comply with the myriad of regulations encourages the building of a strategic partnership which supports a stronger supply chain.

Medical device manufacturers must provide regulatory teams with the tools and resources to ensure smooth and compliant interactions with their linked economic operators as supply chain partners rather than third-party service providers.

KimYoung@instem.com

K Young

References:

EU Commission Blue Guide 2016 (updates currently in draft) https://ec.europa.eu/growth/content/%E2%80%98blue-guide%E2%80%99-implementation-eu-product-rules_en

EU Importer/Distributor Fact Sheet https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/importersdistributors_factsheet_en.pdf

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