Julkaistu numerossa 4/2021

New obligations for medical device distributors

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New obligations for medical device distributors

You have probably purchased a blood pressure monitor, thermometer or surgical masks from, for example, a grocery store, pharmacy or online shop. How do you know the product that you purchased is appropriate? What responsibilities does the seller of a medical device have?

In May 2021, the new medical device regulation caused significant changes that are intended to improve device safety. Although the previous legislation that was valid for 25 years was, in principle, functional and flexible, it also had some major deficiencies that were now corrected.

One of these was the fact that documents to prove device conformity did not have to be presented at any stage unless specifically requested by the purchaser or authority for checking purposes. 

In the new regulation, the manufacturer has sole responsibility for device conformity. However, now the distributor also has new obligations, which include checking device conformity. What are the new requirements for distributors and what impacts will they have on device sales?

Free movement also involves risks

A product’s CE marking is often compared to a passport. It guarantees free product movement in the European Economic Area. This is also the case with medical devices that have CE marking.

There are negative aspects to the free movement of products. It is possible to place products with false CE marking on the market.

There are negative aspects to the free movement of products. It is possible to place unduly CE-marked products on the market. This has also happened in practice. Such products can just as easily enter the market from the Far East as from the European Union (EU) internal market.

Because it is not the market surveillance authority, Finnish Customs cannot stop the import of devices to the European Economic Area without justification. Considering the fact that affixing CE marking to medical devices in the low risk class (such as plasters) is the sole responsibility of the manufacturer, the possibility of malpractice can be attractive.

Distributors must check the device markings

A CE mark does not indicate which regulation governs its affixing to the product. It is difficult for a consumer or device seller to determine the meaning of a CE mark affixed to a product – or even whether the marking is genuine and appropriate.

The new regulation corrected this problem with regard to medical devices. In addition to the CE mark, the sales package must indicate that the product is a medical device.  This is expressed using text or the MD symbol (MD = medical device) (image 1). The IVD symbol (IVD = in vitro diagnostic medical device) (image 1) is already used with in vitro diagnostic devices. However, it’s good to remember that devices marked according to the earlier legislation can still be legally offered for sale until at least spring 2025.

Image 1. MD and IVD symbols on the packaging of medical devices.

The picture shows the patch and pregnancy test packages with the MD and IVD symbols.© Fimea

Every distributor in a device sales chain must ensure that the device manufacturer has prepared the necessary documents and markings, also with consideration to user instructions. The purchaser, on the other hand, is now better able to identify a medical device and be confident that a product inspected by the distributor is appropriate.

More effective supervision

Medical devices that may have falsified CE marking will also be easier to identify in distributor checks based on sampling. If there is even the slightest suspicion of product non-conformity, the distributor may not offer that product for sale.

If there is even the slightest suspicion of product non-conformity, the distributor may not offer that product for sale.

A new national law expands the range of instruments available to an authority, which enables faster and easier decision-making to prohibit the sale of unduly CE marked devices. Earlier it was more difficult to prohibit sales because the procedure in a case of suspected non-conformity was not regulated to a sufficient degree.

When the supervisory authority became aware of non-conformities, the process of investigating them with the device manufacturer was very work-intensive. In the case of an foreign manufacturer, it was almost always necessary to also investigate the issue with the foreign authority in charge

Registration improves traceability

It is clear that medical devices with falsified CE markings or which are deficient in terms of features will occasionally become available on the market. It is now easier to identify device distributors and trace sold products because operators distributing to retail sellers or social and health care must register with Fimea.

Operators distributing to retail sellers or social and health care must register with Fimea.

Upon request, all distributors must also be able to provide Fimea with information about where they procured the devices they are selling and the places to which they have been delivered.

In the future, a unique device identifier (UDI) will also make it easier to identify and trace products. The UDI must be marked on devices within staggered transition periods. All products must have this marking by spring 2027 at the latest. Information about the importer which imported the device into the European Economic Area must also be marked on the product.

One new requirement that significantly promotes device safety is the fact that distributors must systematically summarise the customer feedback received about devices they deliver and report on this to the device manufacturer. The authority must also be notified if device safety is compromised.

Clarification regarding actions permitted for the distributor

The new regulation clarifies and limits some actions permitted for distributors, such as repacking devices, sales under their own brand, and translating user instructions to meet language requirements.

Repacking was not previously regulated in a clear and accurate manner, which led to situations in which wholesale packages were divided into smaller sales lots. In such cases, information about markings and user instructions may have been missing from some of the packages. Devices packed by the manufacturer may no longer be divided into smaller sales lots without assessment by the appropriate inspection body.

The procedures related to translating user instructions have also been specified. In addition, the regulation states that a distributor may not sell a product under its own brand name without agreeing on manufacturer liability with the original manufacturer.

Further requirements also apply to advertising. One that will be visible to consumers and make supervision easier is the fact that advertising must state that the advertisement applies to a medical device.

This is a big change and distributors will have to independently familiarise themselves with the requirements that apply to a distributor.

This represents a big change in the position and obligations of distributors, and it means that distributors will have to independently familiarise themselves with the regulation requirements that apply to distributors.

 

 

The requirements of Regulation (EU) 2017/745 for distributors in a nutshell

It’s a good idea to check the article indicated in brackets to ensure the precise requirements of the regulation.

  • A distributor is any company, operator, wholesaler, shop, pharmacy, kiosk, person, etc. that offers medical devices for sale. However, a manufacturer or importer is not a distributor (art 2.34).

  • Prior to offering a device for sale, distributors must ensure that

    • the device has been CE marked and that the EU declaration of conformity of the device has been drawn up

    • the device is accompanied by user instructions and markings compiled by the manufacturer

    • Information about the party that imported the device to the EU is marked on the package (art 14).

  • If the distributor suspects that a device does not conform, it may not be offered for sale. The device manufacturer must be informed of this matter. If a distributor suspects that the device presents a serious risk or has been falsified, it must also inform Fimea. If the device has already been sold, the distributor must take actions to withdraw the device from the market in cooperation with the manufacturer (art 14).

  • The distributor must ensure that storage and transport conditions for the device comply with the package markings (art 14).

  • The distributor must keep a register of complaints, non-conforming devices and return procedures, as well as recalls and withdrawals. The distributor must keep the manufacturer up to date concerning such monitoring. If the distributor receives complaints or reports about suspected incidents involving the devices it sells, it must immediately send this information to the manufacturer (art 14).

  • A distributor must assume the obligations of manufacturers if it

    • sells a device under its name or registered trade mark without agreeing on this with the manufacturer

    • changes the intended purpose of a device

    • modifies a device in a way that may affect conformity with the applicable requirements (art 16).

  • The distributor may only translate the user instructions compiled by the manufacturer and provide additional information about the device or change the outer packaging if it has a quality system in place for the activity in question, and if this activity has been audited by an inspection body. Any such activity must be registered with Fimea before it can start (art 16).

  • Distributors must cooperate with manufacturers in order to ensure that products are traceable. A distributor must be able to provide Fimea with information about where it purchased the devices it sells and the places to which it has delivered the devices (art 25).

Legislation

Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, EUR-Lex website)

Medical Devices Act 719/2021 (Finlex.fi website)

Updated 17.12.2021 klo 16.00. Incorrect information revised. The correct form is "Retailers or operators distributing to social and health care must register with Fimea.", not "Retailers or operators distributing to social and health care must register with Fimea".
 

Henkilöesittely Jari Knuuttila EN

Jari Knuuttila

PhD
Senior Inspector, Fimea