The Medical Device Regulations for Distributors came into force in mid-May 2021 (after being postponed by 1 year due to Covid-19). Through this regulation, the European Union has streamlined the various fragments of regulations of directives and regulations that previously existing. The idea behind this regulation is to define the level of standard for the quality and safety that is required for medical devices to be made available for sale in Europe.
A distributor refers to any company, natural or legal person in the supply chain, other than the manufacturer and importer (anyone who places a device from a third country on the Union market), that makes a device available on the market, up until the point of putting the product into service.
The activities of a distributor, for the purpose of this regulation include:
- acquisition of medical devices
- holding of medical devices
- and supplying of medical devices
Any product which combines a medicinal product or a substance and a medical device are regulated under this regulation. Should a device have both a medical and non-medical function, it should fulfil both the requirements of devices with and without an intended medical purpose.
Multiple Distributors within the value-chain?
the definition of a distributor which is “A natural or legal person in the supply chain, other then the manufacturer of the importer that makes a device available on the market, up until the point of putting into service”
My question is this, can the same physical product have more than one distributor. Let’s take an example of a Maltese Company which X buys the product from Company Y which is an importer in the EU, and whereby Company X sells to company Z which is also a Maltese company, and is for example a dentist.
Would company X & Z both be classified as Distributors in Malta? In the sense, how would we ensure full traceability, up until the patient of a specific device?
The MDR does not limit the number of economic operators a particular product has.
To better conceptualize, find below two examples.
3rd country Manufacturer A imports its devices into the EU through 3 different Companies 1, 2 and 3.
Since all 3 Companies bring the product directly from outside the EU all 3 are considered as importers for the same device.
EU Manufacturer B distributes its devices across the EU Member States (MS) through a wholesaler X.
Wholesaler X re-distributes the devices to other MS based distributors Y & Z.
X, Y and Z are all considered distributors, regardless if their supplier is the EU manufacturer or another distributor/importer.
In the MDR Article 25 relates to ‘Identification within the supply chain’
1.Distributors and importers shall co-operate with manufacturers or authorized representatives to achieve an appropriate level of traceability of devices.
2.Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(8):
(a) any economic operator to whom they have directly supplied a device;
(b) any economic operator who has directly supplied them with a device;
(c) any health institution or healthcare professional to which they have directly supplied a device.
Source: Medical Device Regulations
This article clearly states the requirement of a form of bookkeeping to allow for traceability.
European vs 3rd party country supplier?
One of our suppliers is based in Japan. The company has an office in the Netherlands that used to take care of the business in Europe when it comes to marketing and support. All orders used to be done through Japan. Now what they did is that they registered the Netherlands office as the importer and all European distributors will place the orders to the Netherlands office and also the payments. The product will still be shipped from Japan.
In this case, the importer would legally be the company in the Netherlands and you would be a distributor since you would be purchasing stock from within the EU market.
Please note that the importer has certain obligations that the MDR lays down if the stock is brought directly from Japan and not from the Netherlands, these obligations of due diligence, including labeling, which are not being carried out by the importer and must therefore be added responsibility from your end.
Medical Device Regulations for Distributors
Within the Regulation (EU) 2017/745 of the European Parliament on medical devices, Article 14 sets out the general obligations of distributors for medical devices.
- Distributors must act with due care in relation to the requirements applicable
- Before placing a device on the market, distributors shall confirm that all the following requirements are met:
- All devices should have a CE Marketing to indicate that they conform to this regulation. In turn, this would mean that these medical devices can be sold freely within the European Union.
- The device has the information supplied by the manufacturer (as per article 10(11) of these regulations
- For imported devices, the importer has complied with the requirements set out in Article 13(3)
- Where applicable, a UDI (Unique Identification system – covered in Article 27 of the medical device regulations)
3. Distributors must make sure that they ensure safe handling of the product. This is done by ensuring that storage or transport conditions comply with the conditions set by the manufacturer. Read more about Good Distribution Practice (GDP) here.
4. Where a distributor has a reason to believe that a device is not in conformity with these regulations, the product in question should not be made available on the market. Moreover, it shall inform the manufacturer, the authorised representative, or the importer, of such deficiencies.
5. Whenever a complaint is received from healthcare professions, patients, or users, about a specific product, it shall inform the manufacturer, the authorised representative, or the importer, of such deficiencies. Moreover, a register of complaints must be kept that includes information on non-conforming devices, and of recalls and withdrawals.
6. Naturally, distributors must provide any information or documentation that is required by the competent authority as deemed necessary.
Should the distributor do any of the following, there are further requirements:
- do any translation of the information supplied by the manufacturer
- change the outer packaging of a device
In such a case, the distributor shall indicate on the device, or if impracticable on its packaging or in a document accompanying the device, the following:
- the activities carried out
- registered trade name/mark
- registered place of business
- address at which it can be contacted
In this case, distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date. Just like the building maintenance report for ISO 27001 Certification, the requirements for the medical device regulation are very specific.
- Is LN321 of 2020 still applicable, given that we will be using the new MDR?
- Yes LN 321 will still be in force under the MDR.
- As distributors, do we need to register with EUDAMED? If so, how do we do this?
- No, Distributors do not need to register under EUDAMED, but will have to register in a National Database. More information and guidelines on the National Database will be issued later this year.
- Given that, as distributors, our suppliers have a representative in Europe, do we need to register our products with EUDAMED? Or does the importer/manufacturer need to take care of this?
- The Manufacturer or the Authorised Representative are legally bound to register the devices with EUDAMED. It is the obligation of distributors/importers to confirm compliance of the devices they distribute/import.
- If we need to register products, do we need to register ALL products that we can sell, or only the products that we are selling already?
- Registration for all products on the EU market should already be in place. Going forward local operators will be obliged to carry out a notification process of all devices they put on the local market.
- Furthermore, as distributors of medical devices, do we need to register with the Medicines Authority?
- Yes, as stated above this will be implemented through a National Database.
- What is the correct procedure to handle a defective product? Moreover, in such a case, who will need to be notified? And are there any specific forms to be filled in?
- The term defective is not specific enough. Should the defect be related to vigilance and therefore be classified as an Incident Report, one must follow the MDR which clearly states each operator’s obligations.
- Do we have to follow specific requirements for transport, for example GDP certification?
- Under the MDR transport and storage conditions need to meet the conditions as set out by the manufacturer for each device.
- Locally we will be implementing a baseline of GDP for medical devices to ensure basic standards.
- surgically means that a surgeon has to use them, or within an operating theatre or any other medical professional? for example radiologist. for example a biopsy gun.
- The term surgical is not defined in the MDR.
- ANNEX VIII CHAPTER I states : A ‘Surgically invasive device’ means: (a) an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and (b) a device which produces penetration other than through a body orifice.
- That being said, we can further guide you if you provide us with specific devices since one explanation cannot be given to cover all the intended uses of different devices.
- when defining the risk class of a product, does the term ‘continuous’ refer to actual use within the patient or availability of the device for the patient? – for example biopsy gun can be used twice for 5 minutes each time within 2 hours. Is the latter still considered as continuous use?
- Continuous use refers to non-stop use. So the example of a biopsy gun which is used for 5 minutes at a time is considered a transient duration of use.
- which products do not need a UDI?
- All products under the MDR require a UDI.
- Kindly see the EU factsheets which can be found on the MMA website for derogation timelines depending on risk class.
- how do we check whether the product is listed on the EUDAMED (including knowing the Class (risk) of the product)
- Risk class is defined by the manufacturer and the Notified body if applicable.
- EUDAMED module for device certification is not yet live. Actors may check devices once module is live.
- does the labelling of details of importers have to be placed on the outside packaging or on the individual packaging of each device (for example box with 5 biopsy guns – do we need to put a label on the outside box, or on each sterile package of each biopsy gun. keep in mind that if we open the box we would be ‘tampering with the packaging’
- Article 13 (3) Importers shall indicate on the device or on its packaging or in a document accompanying the device.
- Please note that under Article 16, changes in pack size shall not be considered to be a modification of a device.
- Therefore, the details should be placed on the unit of sale of the device.
- moreover, for an example of an angiographic catheter that comes in a box of 5, each in a single packet – must the 5 angiographic catheters, and the box have the same UDI (UDI-DI/UDI-PI). And does it make any difference if they are bought and sold as packages of 5, or sold individually?
- As per above
- if a product is sterile we will need to indicate the sterile state – what does this mean? does it mean that the product must have a sticker to confirm that indeed the product is still sterile?
- The manufacturer must abide by current labeling procedures as per ISO 15223.
- In the event that a company will be repackaging or rebranding under their own name, they will become the manufacturer and must abide by the MDR in its entirety as well.
- Article 16 explains size repackaging and sterility.
- Do we need to upload the products that are existing and on the market – for example, 6 beds are already at the client – will we need to register those, or do we only register the products going forward (once the National System is up and running).
- The national system will not record individual units of sale but the device itself. For example, only one entry is required in the database irrespective if there are 6 beds at the client or 60.
- The system is meant to capture devices currently being placed on the market.
- Also, do we need to register also consumables – like cables, batteries (AEDs, ultrasounds etc), AED pads, SPO2 sensors, ECG pads, ECG papers etc
- A consumable is a medical device on its own and therefore is required to follow the MDR in its entirety.
- As per the MDR Article 23 Parts and components, any device placed on the market individually is seen as a device of its own right.
- Spare parts for a machine that needed replacement, would we need to register these parts relating to this product (which is part of the machine)?.
- As above see Article 23.
- Could a product have more than 1 classification? For example, an X-ray machine, which has various components
- If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories for a medical device and for a product listed in Annex XVI shall be classified in their own right separately from the device with which they are used.
- Must all products have an NB (notification body) number after their CE Mark?
- All devices which require a NB for certification must have the NB number after the CE mark.
- This means Class IIa, IIb III and Class Is, Ir and Im.
- We have a package of single-use defibrillator pads and they do not indicate that they are a medical device. Is that needed?
- Defibrillator pads are medical devices and must follow the legislation in full.
- If the device is not marketed as such it is in violation to the law.
- What does ‘clinical investigation’ refer to?
- See the relevant MDR articles and definitions.
- Should consumables have their own IFU (for example infusion line) – or can it refer to the IFU of the infusion pump?
- A consumable is a medical device on its own and therefore is required to follow the MDR in its entirety.
- Regarding the defibrillator pads, they have written on them ‘for use with model x [a particular model of AEDs]’ – is that enough to be compliant with the law, which states that a product has to have written ‘medical device’.
- As per Annex I 23.2 (q) the device should have an indication that the device is a medical device. Therefore the above is not enough as per the law.
- Moreover, does the terms ‘medical device’ have to be written on the label on the outside package, or can it be on the IFU?
- The term should be placed on the label of the device.
- Just to clarify, can you please confirm whether we will need to have the logo for ‘Medical Device’ on the outside label for consumables (such as AED pads and other consumables)
- As per the MDR consumables certified under the new regulations are classified as independent medical devices and therefore require the label to have the full information as per Annex I 23.