Newsletter No 17 September 2020
Subject: DISTRIBUTORS – General obligations: Article 14
As we return all from our well deserved summer break, we hope you all had time to restore for the continued journey into MDR and as committed in our first release of the MDR Newletter, STS Medical Group will continue to accompany you with guidance on a monthly basis.
In this newsletter we would like to focus on the general obligations of Distributors according to art. 14 in Chapter 1.
Distributors are important market players in the chain between the manufacturer and patients. However, up to now, there have been no concrete specifications regarding their tasks and obligations at the European level. The implementation of the Medical Device Regulation (MDR (EU) 2017/745) changes this.
Let´s have a closer look…
(34) ”distributor” means 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.
1) “… act with due care…“, means
- Be aware of your obligations
- ensure your compliance with the regulation
- Act carefully and be aware of your responsibility within the medical device industry
2) Verify the following, before making a device available on the market:
- that there is a CE mark on the device and that the DoC is available (Declaration of conformity)
- instructions for use are included
- Imported devices: check labeling information from the importer
- where applicable: verify that the UDI is assigned
3) Further information – Importers obligations:
- Name, registered trade name or mark, registered place of business and address of the importer is indicated on the device, its packaging, or an accompanying document
- Any additional label does not obscure any information provided by the manufacturer UDI required on the device/ packaging
4) Sampling method: representative of the devices supplied by that distributor:
- you should implement a quality control process with a sampling plan on a risk based approach
„…the device is not in conformity with … this regulation…“
- You shall not make the device available on the market
- Inform the manufacturer and if applicable the EU-REP and the importer
„… the device presents a serious risk or is a falsified device…“
- Inform your competent authority
Falsified Device: (EU) 2017/745, Article 2:
(9) “falsified device” means any device with a false presentation of its identity and/or its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intelectual property rights
5) Storage or transport conditions must comply with conditions set by the manufacturer
You should implement a process for control of storage conditions for the devices as well as for the transport.
6) The device is already delivered (made available on the market) and is
- not in conformity with the regulation:
- Immediately inform the manufacturer (if applicable the EU Rep and/or the importer)
- Co-operate with the manufacturer and the competent authorities
- Presents a serious risk:
- Immediately inform the competent authority of the member state in which the device is made available on the market, with details on the non-conformity and any corrective action taken (corrective action, withdrawal, or recall)
- Inform immediately the manufacturer (EC-Rep; importer)
- Keep a register of complaints, non-conforming devices, recalls, withdrawals
- Keep the manufacturer informed about the monitoring
- Provide the information on request to the manufacturer
(EU) 2017/ 745, Article 2 states in
(27) „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
(62) „recall“ means any measure aimed at achieving the return of a device that has already been made available to the end user
(63) „withdrawal“ means any measure aimed at preventing a device in the supply chain from being further made available on the market
(67) „corrective action“ means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation
8) You should be able to identify for 10 years (15 years in case of implantable devices):
- any economic operator who has directly supplied you with a device
- any economic operator to whom you directly supplied a device
- Any health care professional or health institution to which you have directly supplied a device
You shall storage the UDI of any implantable class III device.
9) (EU) 2017/745 Article 30
Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory.
You should learn about national registration requirements for the member states you whish to make the devices available on the market! Make sure you are always up to date with these provisions.
10) If you do not want to have the obligations of a manufacturer:
- (Do Not) make available on the market a device under your own name, trade name or trademark. (Exception: you have an agreement with the legal manufacturer to do so, and the manufacturer is still identified on the label).
- (Do Not) change the intended purpose of a device
- (Do Not) modify a device in such a way that compliance with applicable requirements may by affected
11) What you CAN DO, you can
- Provision, translation of the IFU and of further information for marketing of the device
- Change the outer packaging, change of pack size, repackaging if carried out in a way that the device is not affected (Remember: Opening sterile packaging will negatively affect the device.)
- Indicate your name, registered place of business, adress, trade name/ mark on the device
- Have in place a quality management system for these activities
- Inform the manufacturer and the competent authorities at least 28 days prior to making available the devices
- Submit a certificate for the QM system issued by a notified body for the activities described above to the competent authorities at least 28 days before making available the devices on the market
Let´s recap shortly the obligations of Distributors
- Verification of CE mark, DoC, IfU, Importer information, UDI Sampling method, risk-based approach
- Information of manufacturer, EU-Rep, Importer in case of devices which are not conform and/ or presenting a serious risk or in case of falsified devices (devices which are not yet available on the market and devices which are already available on the market)
- Control of storage and transport conditions
- Complaint handling
- Ensure traceability of devices
- Keep up to date
This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”.
We are already today all dependent on an effective cooperation. For the MDR implementation, we require even a closer collaboration in order to ensure we all can deliver safe supply to hospitals and patients in the future.
We are confident we’ll be able to continue to supply health care competently on customized surgical procedure sets and small kits.
The next MDR Newsletter will be issued in October. We wish everybody pleasant days.
You want to know more about specific topics? Do you have any questions or comments? Write us!
CEO STS Medical Group
Katarzyna Zofia Chrusciel
Corporate Director Quality Management
and Regulatory Affairs