MDR Implementation: Economic Operator Requirements

Description: Meeting supply chain requirements under the economic operator rules requires a critical look by all parties at their supply chain. The session will answer questions on how to pool resources and gain efficiencies in economic operator compliance in multinational companies with integrated supply chain. Certainly the relationships of independent entities is being evaluated. It is important to have clear understanding of each other’s responsibility and accommodate the relationship you may have.

As Manufacturer, do I need to control “my” Importer? Is he not my customer?
As Importer, do I like to be controlled by the Manufacturer? Is he not my supplier?
Can I have my own subsidiary or sister company acting as Importer and or EC REP?

More important than ever, Economic Operators must confirm compliance with all partners – including agreement validity – to avoid serious regulatory compliance issues and increased enforcement action from EU authorities. Manufacturers should therefore expect to find themselves under scrutiny from new sources while Notified Bodies and
Competent Authorities will have multiple resources for information when conducting investigations.

New Regulatory Affairs roles are to be fulfilled with the Person Responsible for Regulatory Compliance and other entities should carefully consider their roles like for example semi-economic operators ie: service providers and system integrators / procedure pack producers.

The new Market Surveillance Regulation (EU)1020/2019 affects the MDR and the IVDR's Economic Operator regime.

The latest news to BREXIT, SWEXIT and TREXIT in regards to the Economic Operator situation are being reviewed. An example is the import of products from the UK or the requirement of an Authorized Representative for Swiss Manufacturers. Does this lead to reciprocal action that an Authorized Representative may be required in Switzerland.

With approximately 27,000 medical technology companies in Europe, the new requirements affect a vast number of actors. Importers and Distributors will be subject to an unprecedented level of scrutiny and will have to introduce a whole draft of processes to achieve compliance.

Certainly, the liability will be addressed since the Notified Body may verify that. It will most likely be subject to the inspection of an authority.