Bulgaria and Romania admission to the EU and impact for medical device manufacturers

Bulgaria and Romania joined the European Union on 1 January 2007. Several clients have asked us when CE Marking will be required and the registration process for Class 1, IVD and high risk medical devices. The short answer is that CE Marking is required and the same registration and vigilance requirements that apply to most CE countries apply in these countries as well. The Bulgarian authorities have informed us that Bulgarian law governing medical devices is based on the MDD, IVDD and AIMDD, even though these have not officially been adopted by the Bulgarian Parliament yet.

If you do not currently export to these markets, consider expanding into these countries as they have a combined population exceeding 30,000,000 people (Bulgaria at 7,300,000 and Romania at 23,300,000).

If you are already registered and are selling in these countries, you do not need to register your products again. If you do not sell there now and your products require registration in other EU countries, you may need to have your Authorized Representative (EC REP) in Europe register your products with the Bulgarian and Romanian Competent Authorities. Contact your EC REP for more details.

Also, when shipping products to these countries, be sure to apply the same documentation and labeling procedures that apply to other EU countries. Namely, your IFU and labeling needs to be translated into Bulgarian and Romanian regardless of whom uses your products. That said, in some cases you may request a derogation (exemption) for English from the Bulgarian authorities.

Vigilance reporting requirements should follow those outlined in the Medical Device, In Vitro and Active Implantable Directives. We have listed Vigilance contact points with the Bulgarian and Romanian Competent Authorities should you have questions regarding your device.