Is this legal and do you imply something outside proper control?
Medical devices moving through our network are perfectly legal and are a direct consequence of differences in prices between EU Member States and of the development of the Internal Market which guarantees the free movement of goods. However, certain conditions must be respected, namely those derived from the need to protect public health. The word “parallel” simply indicates that the import and marketing of a medical device takes place outside the distribution network of the manufacturer or his licensee.
The EU is discussing a new medical device regulation which will follow up the medical device directive. This is an important opportunity, while the proposals propose a provision for an unique device identifier which will be stored in the extended EUDAMED database. This will increase transparency. Furthermore the medical device will regulate the supply chain which will increase safety, tracking etc. It will bring an integrated market for medical devices closer.
Is this a form of parallel distribution?
Yes. Parallel trade is based on the principle of free movement of goods and has contributed to the development of the Internal Market. The Court has ruled (Case C 44/01 delivered on April 8, 2003 paragraph 63 of the judgement) that “in completing the Internal Market as an area without internal frontiers in which free competition is to be ensured, parallel imports play an important role in preventing the compartmentalisation of national markets”.
Is it safe?
Medical devices moving through our network must comply with all regulations. Certain conditions must be respected, namely those derived from the need to protect public health. These conditions are set forth in the different directives and regulations. All hospitals in our network are regulated in the countries they operate.
Hospitals that supply the network with medical devices must proof that they comply with the regulations. Hospitals have extensive experience in handling medical devices, they do so for their own patients as well.
What kind of activities do you undertake to guard the integrity of the supply chain, traceability, safety, etc?
Guarding the integrity of the supply chain We purchase authorized medical devices from hospitals that operate throughout the European community. The supplying hospital must provide assurance that the medical devices where obtained from the original manufacturer.
The new medical device regulation proposal states that individual organizations have an obligation to ensure that previous links comply with relevant legislation. Schuman is planning a quality assurance certification process (iso 13485:2016) in preparation of the new medical device regulation.
Control of incoming products Each incoming medical device is checked. The check includes the actual product, the packaging, the label and package leaflet. The following is kept in an electronic file
Product name and article code
Name and address of supplying hospital
Date of purchase
Medical devices are not sold until they have a final release.
Checks on the expiry date
Checks on linguistic compliance concerning labelling and instructions of use
Checks on packaging
We have procedures to ensure traceability and recall any medical device distributed when a quality of safety issue occurs.
Storage conditions Medical devices are stored in clean, safe and secure warehouses under conditions specified by the manufacturer. We control temperature, any products exposed during storage to a temperature outside the acceptable range must be quarantined.
Medical devices beyond their expiry date will be destroyed.
Transport conditions Transport of medical devices is in accordance with the requirements of each individual product.
Our post marketing activities
Vigilance We provide manufacturers, through our partner hospital information about adverse reactions, abuse and defect reporting. Furthermore we provide for product recalls in case a manufacturer issue a product recall. Hospitals that are provide us with medical devices have contractual obligation to forward recall information.
Complaints We handle client complaints according written procedures, investigate thoroughly and respond promptly.
Recalls Recalls are handled according written protocols. We have identified a designated person who is responsible for execution and co-ordination of recalls.
When a recall is initiated by the manufacturer or competent authority the supplier hospital will get requested to quarantine all the affected devices and return them to their supplier. Schuman Europe will inform the responsible person in the hospital according to the recall protocol which has been signed with the hospital.
What about labeling and language?
The current medical device directive states that a manufacturer has responsibility for the design, manufacture, packaging and labeling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
We buy devices that are placed on the EU market, which are authorized and are marketed through formal distribution channels.
Article 13.3 (ANNEX I MDD 93/42/EEC) States that the label must bear the following particulars:
(a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;
(b) the details strictly necessary to identify the device and the contents of the packaging especially for the users;
(c) where appropriate, the word ‘STERILE’;
(d) where appropriate, the batch code, preceded by the word ‘LOT’or the serial number;
(e) where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month;
(f) where appropriate, an indication that the device is for single use. A manufacturer’s indication of single use must be consistent across the Community;
(g) if the device is costum-made, the words ‘custom-made device’;
(h) if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’;
(i) any special storage and/or handling conditions;
(j) any special operating instructions;
(k) any warnings and/or precautions to take;
(l) year of manufacture for active devices other than those covered by
(e). This indication may be included in the batch or serial number;
(m) where applicable, method of sterilization;
(n) in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.
Every medical device that moves through our network is checked on correct labeling.
Article 4 of the MDD 93/42/EEC Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.
In the Netherlands, for example, we have the obligation to present the information that comes with the device in Dutch.
We do not repack or relabel medical devices.
Which countries have the lowest prices for medical devices?
It’s not possible to indicate a single country that has the lowest prices. Price depends on several factors which can differ per member state. Manufacturers or his licensee have different pricing strategies based on local competition, regulations etc.
What is your revenue model?
We receive a transaction fee (included in the sales price of the device) and a bonus when targets regarding savings is realized.
What about service?
We understand that some product groups have service included. This service never comes for free. In some countries manufacturers have service technicians that provide support during a procedure. We are not able to assist you with these kind of inquiries. The service levels differ per country. We discuss upfront with which product groups you need additional services as we do not have a service organization, like manufacturers have, to help you with your requests.
We recommend you to contact the manufacturer or the appointed representative When you need specific product information or training. When you buy a product the product must be marketed to your hospital and professionals must have the correct skills in line with the manufacturer instructions.
How does it work in case of a recall or a claim?
The hospital that buys a medical device (through formal distribution channels, directly from manufacturer or licensee) for us keeps electronic track of the goods sold to Schuman Europe. We have invested in state of the art IT infrastructure to keep track of all devices moving through our network.
In case of a recall the manufacturer reports this to the hospital that has sold the product. They inform us, we track the device and inform the hospital that has bought the product. To regulate this we have a strict recall protocol.
What kind of products move and brands do you move through your network?
We focus on disposables. Products vary from disposables used with minimal invasive procedures like PTCA disposables to sterile dressings and much more. Examples of brands that we move through our network are Medtronic, Boston, Terumo, Johnson & Johnson, Covidien, B Braun, etc.
Transparency +Competition =Buying power delivered
Keeping healthcare accessible affordable throughout the EU.