Compliance assessment of medical products in the EU

What difficulties will medical equipment exporters encounter in relation to the compliance assessment caused by the new EU regulations?  

The new rules of the EU that set quality and safety standards for medical equipment will be established by the Regulations of the European Union 2017/745 on Medical Equipment that will come into force in May 2020 and fully replace the current Directive of the EU 90/385/EEC and 93/42/EEC. Half a year only remains till the moment when the new rules come into effect, however, the grounds for their application have not been prepared yet. The new regulations suppose stricter rules for medical products marketing and control of the equipment that has already been released.

The main problem is the fact that currently only 7 certification bodies are accredited (notified) among those authorized to assess conformance of products under the new regulations. It is far from enough to provide producers of medical goods with necessary certificates in order they could launch their products in the market. It directly involves exporters – such a number of notified laboratories would hardly be able to cover the domestic market, to say nothing about compliance of export products.

The new rules are established by the Regulations 2017/746 on diagnostic units in vitro, that will come into force in May 2022. For test performance under these regulations only two bodies have been accredited.

The idea of the renewed regulations in relation to medical equipment is as follows:


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