While big changes are on the way, the regulatory environment has already taken several major steps towards tougher enforcement. Many manufacturers have already felt this through increased demands by Notified Bodies and these certification bodies are on notice to shape up further. The Commission’s audits have contributed to the disappearance of 25% of the Notified Bodies in the last couple of years. How many more organizations might drop out?
Moreover, although the system created by the new Regulations is evolutionary rather than revolutionary, it contains several new and untested concepts that could seriously undermine it if not effectively implemented. For instance the increased emphasis on post market surveillance relies critically on a centralised database and a new traceability system.
The estimated life time of the new regulatory system is probably 20 to 30 years. This period will see an accelerating rate of scientific and technological development. It will become a world of eHealth with diagnostic sensors in, on and near our bodies monitoring us 24/7. We will be cured by nanobots roaming in our bodies and we may be living in an augmented reality with our handicaps eliminated and our capabilities enhanced by artificial intelligence embedded within our bodies or connected to it.
Against this background of regulatory change and sci-fi speculation, the EU faces an uncertain political future. Populist movements are attacking it. The referendum in UK to leave the EU was its first major success. Will other Member States follow this example? Will EU reform itself to survive? What will be the consequences to CE marking, Notified Bodies and authorised representatives in UK?