Description

What is the role of the importer, according to EU MDR? The requirements for this role have changed since the new regulation went into effect in May 2021 and it's important to understand the extent and impact of these changes.

In this episode of the Global Medical Device Podcast, Jon Speer talks to René Van De Zande with MedEnvoy Global, a specialty solution for European regulatory compliance that offers importer representation services. In addition, René founded EMERGO in 1997, later becoming what's known today as EMERGO by UL.

Listen to this episode as Jon and René discuss expectations, criteria, and obligations for importers under EU MDR and how this role should be managed for post-market surveillance, tracking, labeling, translations, and complaints.

Some highlights of this episode include:

• Only two economic operators can be held responsible for placing a device on the market - a legal manufacturer that resides in the European Union or an importer.
• EU MDR does not clearly define who is who in the supply chain when it comes to economic operators. Articles 11, 13, and 14 overlap activities, obligations, and responsibilities for authorized representatives, importers, and distributors.
• According to René, there are three kinds of distributors: 1. Takes on the role of importer, as well; 2. Capable of taking on the importer role; and 3. Refuses to take on extra liability as the importer.
• Conduct proper due diligence when selecting an importer. First, map out who is who within your supply chain. Are there multiple distributors with quality agreements in place? Are obligations properly addressed to be met?
• Importers and/or distributors should have a quality management system (QMS) that complies with ISO 13485 and MDR to fulfill obligations.
• Person Responsible for Regulatory Compliance (PRRC) and importers are definitely different. PRRC is within an organization, and importers are outside representatives hired to provide services.

Memorable Quotes from René Van De Zande:

“It’s here, and it’s here to stay. There are no delays - at least not for the MDR. Since May 26, it’s alive and kicking.”

“The role of the importer is a critical one because there are only two of the economic operators that can be held responsible for placing a device on the market.”

“The MDR has not clearly defined who is who in the supply chain when it comes to economic operators.”

“You need to do proper due diligence. First, you need to map out as a company, who is who within your supply chain.”

Links:

René Van De Zande on LinkedIn

MedEnvoy Global

Emergo

Underwriters Laboratories (UL)

European Union - Medical Device Regulation (EU MDR)

Economic Operators Guidance Document

Medical Devices Directive (MDD)

EU In-Vitro Diagnostics Regulation (IVDR)

ISO...