Europe is not a Perfect Single Market
Manufacturers in Europe and exporters to Europe must take care and not think that CE marking will give them a legal right to sell medical devices in every European country.
Whereas the USA, Japan and most other countries have a single Medical Device Regulatory Authority, Europe has 32 Competent Authorities. So for a few products the European Competent Authorities do not agree on whether a product is a medical device, a drug or even a consumer product. For some medical devices they do not agree on the classification.
Product category differences
Examples of products that are considered devices in some countries and not others include dermal fillers for cosmetic use, medical gas pipeline installations and tooth whiteners. For such products it is the responsibility of the manufacturer to check the current legal status in each country where the product is to be sold. This is to avoid possible legal action being taken against them. For the most up to date information and interpretations on a product’s legal status in a given country manufacturers you are best to use local contacts or distributors.
Differences in classification of medical devices
When differences in classification occur, where the same conformity assessment option is possible (i.e. a device being IIa or IIb under MDD), there is not usually a significant problem. Where the differences necessitate a different conformity assessment option under MDD or IVDD this is a problem. Examples of such devices include saline washes that can be Class IIa or Class III depending on the country; and point of care pharmacy blood analysis services which can be considered self test devices or for professional use dependent on the country.
Always stay informed and aware of differences
This should not dissuade you from trying to sell your medical devices in the €100 billion medical device market but manufacturers must be aware of products where there are different interpretations and inform sales or export departments to take care. Normally SGS can indicate to clients the products where there are known country differences, however as specific country status does change, the position in individual countries must be the final responsibility of the legal manufacturer or authorized representative.
Contact us today to see how we can help your business.
Medical Device Team
The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 67,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.