Due to the fact that the medical devices that we handle are related to public health, we must operate at a high level of quality assurance. We are obliged to comply with the same distribution regulations as other players. Safety is of utmost importance.
It is important to understand our role in the distribution chain. We do not put products on the EU market. Manufacturers or appointed representatives do so. The responsibilities for manufacturers or their appointed representatives are more stringent. Organizations that put medical devices on the market need to prove that the device is safe and can bare a CE mark.
We buy authorized medical devices that are put on the EU internal market through formal distribution channels. We would like to explain you two different regulatory aspects that are important for our network. Regulatory affairs concerning parallel distribution and directives/regulations concerning medical devices.
According to the European commission parallel imports are products imported into one Member State from another and placed on the market in the destination Member State, outside the manufacturer’s or its licensed distributor’s formal channels (click here for the original press release)
It is important to understand that we move genuine, original branded medical devices through our network, which are authorized in accordance with EU legislation and marketed by the manufacturer or his appointed representative.
In our daily work we embody two basic principles when we move goods through our network: the free movement of goods and the exhaustion of IP right. Due to the free movement of goods principle we are free to buy and move authorized medical devices in every member state. The principle of exhaustion of IP rights protects us while manufacturers and appointed representatives are not allowed to prevent trade after a product has been put on the internal market, in other words when the IP rights have been exhausted.
The Commision press release mentions that ‘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”.
On a day to day basis we integrate the EU internal market for medical devices and fight against compartmentalization.
Any medical device placed on the European market must comply with EU legislation. Devices conforming with legislation must have a CE mark applied. The core of regulatory framework consists of a directive regarding active implantable medical devices (like pacemakers), a directive regarding medical devices and a directive regarding in vitro diagnostic medical devices.
We do not move active implantable and in vitro diagnostic medical devices. The directive for general medical devices regulates the devices that we move through our network. The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonize the laws relating to medical devices throughout the EU.
A manufacturer or appointed representative can legally place a medical device on the European market when the requirements of the MD Directive (click here for the webpage concerning the directive on the webiste of the European Commission). are met. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on March 21, 2010.
When a product has been put on EU market by the manufacturer or the appointed representative and bears a CE mark, the product is by definition authorized and identical in every member state.
It is important to understand that we move genuine, original branded medical devices through our network, which are authorized in accordance with EU legislation and marketed by the manufacturer or his appointed representative.
In 2012 the European commission proposed a regulation on medical devices (to replace: Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices, click here for press release).
We’ve been waiting for the medical device regulation, and welcome this policy. In our view the new medical device regulation will help us to realize our passion for creating more transparency and competition.
The commission states that patients will benefit while all devices have to undergo thorough assessment of safety and performance. Control processes will be radically reinforced. Healthcare professionals will have access to better information. Organizations in the distribution chain will benefit from clearer rules, easier trading between EU countries and a level playing field.
Main elements of the proposals that is of importance to our network includes
1. Clearer rights and responsibilities for manufacturers, importers and distributors, applying also to diagnostic services and internet sales;
2. Extended database on medical devices, providing comprehensive and public information on products available on the EU market. Patients, healthcare professionals and the public at large will have access to the key data concerning medical devices available in Europe, allowing them to make better informed decisions;
3. Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns. A Unique Device Identification system will be introduced to enhance post-market safety of medical devices, to help to reduce medical errors and to fight against counterfeiting;
The new medical device regulation is expected to be adopted in 2016. We are following the developments and will do everything to comply with new regulations.
The effect of the new MDR on us and our network.
Responsibilities
While obligations and responsibilities of economic operators are not stated clearly enough in the current Directives, and can only be understood by analyzing the different chapters throughout the documents, the medical device regulation proposals introduces the term economic operator to define manufacturer, authorized representative, importer and distributor, and stresses the importance of a strict supply chain control mechanism and imposes autonomous obligations at different stages of the supply chain.
Each link in the supply chain has to look back to check whether the previous links are in compliance with the applicable requirements.
In the medical device regulation proposals Schuman Europe and the partners in the hospital2hospital network are considered as distributors in the supply chain taking any subsequent actions after the product has been placed on the market. The proposals state that distributors have to act with particular care not to place non-compliant products on the market. Furthermore, he will have to be able to demonstrate that to the surveillance authorities.
Schuman Europe and hospitals in our network, as distributors, have the responsibility to ensure that
1. The manufacturer and, i.e. all parts upstream, are in compliance.
2. The products are accompanied by the appropriate information, provided by the manufacturer, and bear the CE conformity mark.
3. Make sure that the device is labelled with their contact details
4. Take autonomously corrective actions (e.g. undertake recalls and reports to the authorities)
5. Engage in post market surveillance activities and inform the other relevant economic operators if a device presents a risk or if an incident is reported.
6. They will have to make an evaluation on whether the device is conform and, if not, bring it into conformity, withdraw or recall it
Track & traceability
The new medical device regulation proposal introduces the establishment of a unique device identification (UDI) system. That is harmonized at European level. The proposal also provides for an enhanced traceability of devices throughout the supply chain by increasing the responsibilities of the economic operators.
The current medical device directive did not provide for harmonized traceability of medical devices. Member states introduced their own tracking and tracing requirements.
However Schuman Europe has always kept trace of the medical devices moving through our network by investing in a robust IT infrastructure in which we can trace every single device based on lot numbers provided by manufacturers when put on the market.
In the new proposals all economic operators will have to store and keep all unique device identifiers (device and production identifiers) of the devices they have supplied or they have been supplied with.