An adapted GR strategy: Working on both sides of the fence

MKPS took on a non-EU client who wanted to get established in the Union in order to be able to continue their business regarding certification of medical products. In order to get the client established and properly certified MKPS had to work for two and a half years both with the client and the various state agencies to make it happen.

The work included:

• Making the relevant state agencies aware of their need and obligation within the EU regulations to establish their own capabilities in the certification process, actively advising them on how to do it and monitoring the process both in Zagreb and in Brussels;
• Helping the client to fulfil their obligations through a series of applications, audits, corrections and presentations both to the local and EU authorities;
• Actively working to mitigate the effect of the COVID-19 pandemic on the process - constantly monitoring the progress of both sides and exercising pressure in order to make sure the process is not derailed, stalled or entirely stopped;
• Continually educating both sides on their respective duties in each stage of the process. After two and a half years the client was successful in their application.

The work, however, continues since there are new requirements, a constant need to monitor compliance with the very strict criteria as well as opportunities for expanded scope. Drawing from its vast experience of the EU regulatory landscape and processes, as well as the inner workings of the Croatian public sector MKPS was able to make a success of a rather complex case with many technical and to an extent, political challenges.

Miroslav Kovačić CEO at MKPS