Originally Published EMDM
January/February 2004
INDUSTRY NEWS
Growing Pains: EU Enlargement Poses Regulatory Challenges For Device Companies |
When 10 Central and East European (CEE) countries join the European Union on May 1, medical device manufacturers can cheer the dismantling of another set of trade barriers. However, some uncertainties regarding regulatory issues have yet to be resolved. Some of these were aired during Eucomed’s recent technical forum in Brussels.
One question involves certification. Currently, local certificates are required to place a medical device on the market in each of the acceding countries. The expectation is that on May 1 these certificates will cease to be valid, said Alessandro Slama, regulatory affairs manager at Baxter (Trieste, Italy). CE marking should be the only necessity, he noted.
This raises the question of whether local notified bodies will issue CE marking “automatically.” Currently, the Hungarian certification institute, ORKI, is the only accredited notified body. Steve Owen, head of the UK competent authority for medical devices, said that he would be concerned if existing accreditation bodies were automatically notified. They do not necessarily represent the same thing.
Furthermore, how long will products in stock on May 1 be allowed to be sold with the former country mark in lieu of CE marking? asked Slama. This issue could pose a problem for manufacturers, according to some delegates from the CEE countries. Slovenia and Malta will require all products to be CE marked. Slovakia and Cyprus, on the other hand, expect some non–CE-marked products already on their territory to continue to be sold. There is no deadline for market removal of such products.
In Poland, the Czech Republic, Hungary, Slovakia, and Slovenia, device manufacturers must have a local authorized representative in order to sell their products. If there are no legal provisions to accept an EU representative after May 1, “we will have an issue with compliance,” said Slama.
Regulatory requirements in some CEE countries far exceed those of the Medical Devices Directive (MDD). Manufacturers are concerned that they will need to comply with a national documentation process in addition to the MDD. In Poland, for instance, extensive documentation is needed for Class I devices. All products placed on the market before October 1, 2002, had to be reregistered by October 1, 2003.
“Half of the medical device industry in Poland did not meet the deadline. Therefore, there are still loads of ‘illegal’ medical devices on the market that lack new notifications,” said Dominik Reterski, regulatory affairs specialist at Tyco Healthcare Poland (Warsaw). The lack of compliance should not come as a surprise. The registration process was riddled with problems. The Office for Registration set up to manage the new medical device law proved to be inefficient. In addition, manufacturers had to complete the procedure for devices that had already undergone a costly and time-consuming approval process under the former law.
It is unclear what the situation will be in May with the current valid registration certificates. Representatives of the Ministry of Health, the Office for Registration, the Polish Hygiene Institute (PZH), and trade association POLMED are working on amendments to the Medical Devices Act. Although there has been no official statement, the indication is that there will be no changes to certificates, according to Reterski.
The adoption of the Medical Devices Act, scheduled for May 2004, will help to simplify the notification process. But it won’t be a panacea. It appears likely, for example, that fees will be maintained for individual products. “This is not acceptable,” said Reterski. Industry will push to have those charges applied to each application form, which can list multiple products.
On the positive side, there will be fewer requirements for Class I devices in Poland. Also, “we will no longer have to wait until the notification process is over to get a full notification or approval. The only thing that a medical device distributor or producer will have to do is to file his application,” said Reterski. “That’s it.”
Jeanette Marchant
Copyright ©2003 European Medical Device Manufacturer
