Additionally, we may see an effect on small to mid-size U.S.-based revenue-generating companies that have been looking to Europe to expand their businesses, as well as all companies that already have an approved device on the market in Europe. In these cases, the devices initially went through an easy process and may have to go back to re-submit under the new regulations — there might not be "grandfathering."

DMN: How can medical device companies prepare for these changes?


PT: Medical device companies must watch the developments carefully and plan ahead. Be prepared that moving forward, getting approval in the EU could be as costly and lengthy a process as in the U.S., so companies should factor it into budgeting and financing estimates.

In addition, do not depend on the historical strategy of getting an easy approval first in Europe to generate revenues to lessen financing requirements. Begin taking a look at other countries where companies may be able to get approval more quickly than the EU to start generating some revenues and data there. As I mentioned above, assume that any devices companies already have on the market in the EU might have to go back to square one and be resubmitted through the new process, as companies might not be allowed to grandfather products.

Companies should take the approach that there are no free lunches. One needs to design and develop medical devices in a thorough and thoughtful manner, building up all of the necessary clinical data to demonstrate strong safety, efficacy, clinical benefit/improved outcomes for patients, and economic benefit for clinical providers and payers. If a device is weak in one of these areas, companies might need to rethink design and development or the target market.

DMN: When will the new CE marking process be effective and when do you predict we'll make these changes?

PT: There is an election in the EU in about a year from now and the Parliament and Commission will change over in June 2014. If lawmakers in the EU are able to work quickly and get laws passed before the election, then the new process could be become effective by early 2014. However, some of the Parliament members are dragging their feet a bit, because near the end of their term they would rather not deal with the politics of this issue.

The new CE marking process will be effective either by early 2014, or possibly after the end of 2015. If laws do not get passed before June 2014, then we believe that the changes could be delayed to at least 12-18 months past June 2014 (possibly into the 2015/2016 time frame) because the new lawmakers would need time to evaluate and formulate their stance on the issue.

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