Level of economic development in Europe is higher than the continents, the medical device market is relatively mature, relatively speaking, with the exception of Albania, Bulgaria and a few other countries, other European countries, a good industrial base, the higher the level of hospital equipment. Europe is not only medical device industry is well developed, but also the world\\ s leading medical device market.
According to foreign data show that in 2010, the global medical device market, total sales of approximately € 184.9 billion (equivalent to more than 23 billion U.S. dollars), of which about 30% in Europe, 553 million euros, after the United States is the world\\ s first second largest medical device market. Germany, France, Britain, Italy and Switzerland, the European medical device market, together accounting for 76% of the medical device market, while other European countries, the total medical device market, only the remaining 1 / 4 share. This reflects the European medical device market is highly intensive.
CE certification is a stepping stone
Many of China\\ s current domestic medical device manufacturers have products into the European market will, but most domestic manufacturers of the situation in Europe is poorly understood.
Depending on the classification of medical devices, the EU has been issued three directives on medical devices, in order to coordinate the European medical device product management practices. The world of medical device manufacturers want their products into the European market must follow the above requirements. These three products access to the medical device directives are: Active Implantable Medical Devices Directive (AIMDD, 90/335/EEC), Medical Devices Directive (MDD, 93/42/EEC) and in vitro diagnostic devices directive ( IVDD, 98/79EEC).
In the above three instructions to the second Directive (MDD) of the widest application, including almost all the exports of China\\ s medical device products, such as sanitation materials and medical dressings, medical catheters, breathing machine, various types of endoscopes and patient monitors and so on.
To develop the domestic manufacturers in Europe, the EU must be CE certification, which is exported to the EU market access to medical products qualification. It is understood that manufacturers must be in accordance with ISO13460 and other quality control production line of new provisions, in order to achieve the production level of market acceptance in Europe, and that the EU will from time to time send personnel on-site inspection. EU medical device product quality assurance system is the implementation of more stringent EN46001, which issued in the EU are detailed in Appendix MDD implementing rules and regulations, China\\ s manufacturers and should be carefully studied with reference to the requirement of production. So far, there are over 100 enterprises in China issued by the European Union CE certification. CE certification issued by the equivalent of U.S. FDA 510 (K) regulations. But generally speaking, in the EU market of medical products faster rate than the United States.
Proposal to open up Europe
However, even if has been CE certification, it does not guarantee that the product can be quickly available in Europe. Foreign firms in the EU CE certification later, how to successfully enter the European market? For this problem, the United States Cleveland Medical Device Industry Association, Mr. Paz made some suggestions, a good reference and learning:
First, with the large amount of the major European procurement director of medical doctors in hospitals to make friends, so they understand your product and become familiar with. Because only first obtain a large hospital trust, small hospitals will be attracted.
Second, find product agents in European countries is also a good way. If the company small, economic strength is not strong, then you want a shortcut to enter the European market only to find a local agent who. If you can find a reliable agent in Europe, means that the product has entered the European market gates.
Third, if a higher price, then it must be in Germany, France, Britain, Italy and Switzerland and other European countries, important clinical trials of medical products.
Not recognized by doctors in Europe and outside Europe countries are doing clinical trials, they believe the hospital made famous European clinical trial results. Enterprises must be prepared to do clinical trials in Europe, funding preparation. This investment is worth it, once the product in Europe, the economic return is considerable.
Fourth, the small product should look for distributors in Europe. If exports are relatively low economic value of health materials, medical dressings and low-cost low-end products such as disposable syringes, it might be the product directly by the European distributor sales throughout Europe, so that they share some profits.
Related>>> EU regulatory legislation reforming Yixie
As the legal framework for the complex and can not follow up on emerging technologies and regulations of the Member States in the lack of uniformity in the implementation process and other reasons, the EU regulatory rules by the multi-Yi Xie blamed.
In 2007, the EU issued a directive Yixie regulatory rules changes, and implemented in 2010. The directive adds Yixie pre-market monitoring requirements, increased demand for some of the clinical data standards, and will be added to Yixie medical software list. In addition, in May 1, the national authorities (NCA) has been asked to the European medical device database (EUDAMED) to submit the relevant product certification, pre-market clinical investigations and monitoring data. The database can only be accessed by NCA and the European Commission, aims to streamline the listing process Yi Xie. Prior to this, the new Yixie must be individually listed to inform members of the various target markets, and now you can save this step.
Despite all these changes, Yi Xie regulatory rules are still faced with various criticisms. November 2010, the European Commission published a directive to modify its schedule Yi Xie and Yi Xie rewrite the EU Directive 2012 legislative agenda as the first step.
So far, rewritten Yixie instructions not yet finalized the details of the proposal. Commission announced the schedule did not give a specific reform plan, but added to provide a range of possible options, including a wider range of commands to replace the MDD and AIMDD, issued a directive to upgrade to replace the existing IVDD, by conformity assessment procedures will streamline and clarify the key concepts and terminology and other ways to promote consistency between the EEA countries.
Accordance with the schedule and is expected to begin in the first quarter of 2012, the implementation of the revised Yixie instructions. However, the European Commission has so far not provided the final reform bill deadline, the final regulations will be rewritten and the European Union Council of the European Parliament by the audits.