With the new MDR’s coming closer it becomes urgent for companies present in the EU market to sort all matter of distribution issues. The EU distinguishes several levels of economic actors: the Manufacturer, the Authorized Representative, the Importer and the Distributor, and each of these actors is now referred to in the Regulations. In this Read More …
Tag: EU Market Entry
MedTech Manufacturers, EU Distribution: Authorized Representative Agreements (Part 1).
With the new MDR’s coming closer it becomes urgent for companies present on the EU market to sort all matter of distribution issues. The EU distinguishes several levels of Economic Operators: Manufacturer, Authorized Representative (AR), Importer and Distributor. In this first article we will review the role of the Authorized Representative. The Authorized Representative Read More …
Skip Domestic. Commercialize in a Foreign Market first?
Over he last few months, several companies that had not commercialized their products in their domestic markets asked me about entering one or another foreign market. Normally, I tell them that’s probably not a good idea. The reasons behind my statement are straightforward. Entering a foreign market is more difficult than addressing your Read More …
Should US MedTech companies be concerned about the new EU Medical Device Regulations?
The EU market has always been attractive for US MedTech companies. Obtaining approval to sell into the EU market has in the past always been easier than getting approval to sell in the US. That may soon change in view of the new EU Medical Device Regulations. For a long time, US manufacturers preferred to Read More …
Assess and Protect against Product Liability Claims when Entering a Foreign Market
When you enter a Foreign Market you will probably face a Product Liability regime different than the one in your home country (Similar But Still Separate and Distinct). Chances are your company is not intimately familiar with the risks in the market you plan to enter. Our experience has shown that “the unknown” can often Read More …