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Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

Tel.: 07131 2774-40
regulatoryaffairs(at)seleon.de

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25.05.2021

RIDING THE WAVE MEANS BEING SUCCESSFUL!

Face reality: The MDR is coming, albeit one year late, but it will be valid at the end of the month. What does this entail for you as a distributor? Are you aware of your obligations and are they already integrated into your daily business?

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What a European distributor has to pay attention to with the entry into force of the MDR and what obligations await him.

You can't stop MDR, but you can learn to act MDR-compliant.

On 26 May 2021, the MDR comes into force with a one-year delay due to the COVID 19 pandemic, yet many distributors feel like they have been hit by a maverick wave with the new regulation. But what new obligations do they actually expect?

 

Who is distributor according to MDR?

First of all, it should be noted that the term "distributor" appears for the first time in the MDR and did not exist previously under the MDD. A distributor is defined as "any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market up until the point of putting into service" (Art. 2, MDR).

One novelty is that in the supply chain of economic operators, compliance with the applicable requirements must be ensured by each individual economic operator.

We have already reported on the interplay between the individual economic actors in our blog post "Know who you are. Knowing what you have to do", which primarily highlights the role of importers.

 

What deadlines apply to all economic operators?

Products lawfully placed on the market before or under the MDD may, depending on their product class, be placed on the market until the

  • 26 May 2021: Class 1 under MDD and MDR, without Notified Body;
  • 26. May 2022: certificates based on Annex IV of the directives 90/385/EEC or 93/42/EEC
  • 26 May 2024: under MDD Class I without Notified Body, under MDR Class Im, Is, Ir or higher with Notified Body (and other conformity assessment than Annex IV)
  • Until the expiry of the MDD certificate: under MDD with Notified Body and also under MDR with Notified Body.

placed on the market for the first time. Products that are not yet MDR-compliant can therefore be sold to distributors before the respective expiry date and can be resold and put into service by the distributor up to a maximum of 25 May 2025. Of course, the general specifications of the products and their service life must also be taken into account.

 

What obligations must the distributor now expect?

The general obligations of distributors are regulated in Article 14 of the MDR. Here, not only the obligations regarding product conformity, but also the relationships between distributors and other economic operators are specified.

The following is a brief overview of the general obligations of a distributor before making the product available on the market under Article 14 of the MDR:
 

a) Checking the CE marking and the EU declaration of conformity

Each economic operator in the supply chain must therefore verify that the equipment bears a CE marking and is properly labelled and that an EU declaration of conformity has been issued before placing it on the market (verification of the information accompanying the product from the manufacturer), so that the user can assume verified product safety.

The distributor shall verify that the patient or user information (instructions for use, installation instructions, etc.) is available in the relevant national language, complies with the requirements of Section 23 of Annex I, and is indelible, legible and clearly understood by the intended user or patient.

He shall also check whether, if applicable, the name and contact details of an importer are present on the product, on the packaging or on a document accompanying the product if the manufacturer is established outside the EU.
 

b) Verification of the UDI for the device in accordance with Article 27 of the MDR

Every medical device according to the regulatory requirements of MDR 2017/745 must bear the Unique Device Identification (UDI). Before making the product available on the market, the distributor is obliged to check whether the product is labelled accordingly with the UDI code and whether the declaration of conformity contains the basic UDI. The deadlines for affixing the UDI carrier to the products must be observed:

Product packaging

  • Implants and Class III devices: 26 May 2021
  • Class IIa and IIb products: 26 May 2023
  • Class I products: 26 May 2025

Direct marking of the products

  • Implants and Class III devices: 26 May 2023
  • Class IIa and IIb products: 26 May 2025
  • Class I products: 26 May 2027
     

c) Capture the UDI for specific products

If a distributor purchases and sells implantable class III devices, he is obliged to record and store the UDI (UDI-DI and UDI-PI). This shall preferably be implemented with electronic solutions.

In addition, the MDR leaves open the possibility that further product(s)/product groups/categories will also have to be recorded electronically by distributors and all economic operators on a mandatory basis.

 

d) Application of a sampling procedure

According to the MDR, the described points "Checking the CE marking and the EU declaration of conformity", "Checking the information accompanying the device from the manufacturer" and "Checking the UDI for the device in accordance with Article 27 of the MDR" can also be checked with the help of a sampling procedure that is representative for the supplied devices. In the EU FAQs covering this point, however, the wording is slightly different and no longer reads "may" but "should":

"The Regulations describe the roles and responsibilities of distributors, who should make sure, by representative sampling, that the devices they distribute are compliant with the obligations described in MDR/IVDR Article 14."

Possible solutions can be mapped in a procedural instruction that contains the statistical basis for determining the sample size as well as a checklist for checking the labelling.

 

e) Information and cooperation with manufacturers, economic operators and authorities

If the distributor considers that a product presents a serious risk, he must inform the manufacturer, the authorised representative, the importer or the competent authorities.

He shall cooperate in bringing the product into conformity or in recalling the product, depending on the risk. If a competent authority requests samples of the product, the distributor must make them available to the authority free of charge. If this is not possible (e.g. due to the product type/size), he must grant access to the product.

A well-functioning communication between all economic actors involved (at least manufacturer and distributor, in case of non-European manufacturers also with the authorised representative and the importer) is of great importance. This is important in two respects: on the one hand for the conformity of the products, especially in case of recalls or complaints as well as (suspected) incidents; on the other hand in order to continuously optimise products and services and to be able to offer the best possible care to the patient.

Here, too, it makes sense to introduce a procedural instruction on the exact procedure.

 

f) Initiation of corrective actions for non-compliant products in consultation with the manufacturer, importer or authorised representative, or the authorities.

If the distributor notices a non-conformity, he must immediately inform the manufacturer (or, in the case of non-European manufacturers, his authorised representative). If non-conforming products occur, the distributor must react accordingly and take appropriate measures. Depending on the situation, these should be, for example:

  • Contact the customer and inform them of the non-delivery/delay in delivery.
  • Contacting the client and informing them about upcoming corrections
  • Inform the manufacturer about the corrective measures
  • Do not make the product available on the market until it complies with the requirements of the MDR
  • If there is reason to believe that the product poses a serious risk or could be a counterfeit product, inform the competent authority in his country
     

g) establishment of a register for complaints, non-conforming products and recalls

Every distributor of medical devices must keep a register of all complaints received, non-conforming products as well as recalls and withdrawals. In other words, if a customer/user contacts them with a complaint or similar, they must record this in a documented manner.

He must inform and keep informed the manufacturer, the authorised representative (if the manufacturer is not located in the EU) and the importer (also only if the manufacturer is not located in the EU) about the recorded entries in the register.
 

h) Maintain storage and transport conditions according to the manufacturer's specifications.

The distributor must ensure that the goods are stored and transported as specified by the manufacturer. This information can be found on the product labelling and accompanying information, but in the best case it is also part of the negotiations and specifications within the framework of contracts. Corresponding records are to be provided and kept in accordance with the necessary precautions and storage obligations.

 

General Concluding

If quality management according to the ISO 9001 standard is applied, the organisation (in this case the distributor) is also obliged to review the effectiveness of the corrective and monitoring actions taken and to update the risks and opportunities identified during planning.

In view of the MDR, a functioning quality management system is an almost unavoidable aspect in order to embed the required activities in the company in a meaningful way via the above-mentioned procedural instructions.

Please note that under Article 16 you must assume manufacturer obligations under certain circumstances, if you make changes to the product or to the labelling. More on this shortly here.

The huge MDR wave is now pressing all economic operators. The question is, are you ready to surf it too or are you still wobbly on the board? We are happy to offer you the necessary regulatory support for an MDR-compliant QMS for you as a distributor, importer or manufacturer. Simply contact us without obligation. So that you can still swim on top of the wave after 26 May 2021.

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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