EU IVD Regulation: every part of the supply chain has a new set of obligations to legally abide by

It is quite an easy assumption to make, that if your business is not a Manufacturer of IVD devices who are active in the EU market, then this new regulation does not affect you.  Surely this is just about devices and their makers?

On the contrary, as of May 2022, every part of the IVD supply chain has a new set of obligations to legally abide by.  Furthermore, there are responsibilities for double-checking other parts of the supply chain that are either up or downstream of your own operations.  Legal requirements and liability go hand in hand, so it is important to mitigate business risks as far as possible.

So, what are the challenges ahead and how will they affect your business?

Firstly, it’s important to become accustomed with the term Economic Operator.  As defined within the regulation these are Manufacturer, Authorised Representative, Importer and Distributor, or MAID for short.

Key Economic Operator Responsibilities

With the new regulation coming into force, the responsibilities for each area have been updated:

For Manufacturers:

• Implement a Quality Management System
• Observe regulatory requirements for product realisation
• Conduct risk management
• Performance Evaluation
• Prepare technical documentation to new requirements
• Assign UDI labelling
• Conduct PMS & vigilance
• Have liability
• Person Responsible for Regulatory Compliance
• EUDAMED registration
• Register products with a Notified Body
• If outside the EU (a third country), designate an Authorised Representative

For Authorised Representatives:

• Have liability for Manufacturers Products
• Person Responsible for Regulatory Compliance
• EUDAMED registration
• Verify Manufacturer’s declaration of conformity and technical documentation
• Hold copies of D of C and technical documentation
• Register products with a Notified Body
• Perform field corrective actions where necessary
• Deal with complaints and suspected incidents

For Importers:

• Verify device compliance
• Add contact details to device labelling
• EUDAMED registration
• Safeguard storage and transport conditions
• Reporting non conformities, complaints and incidents
• Hold copies of D of C
• Cooperation with Competent Authorities
• Assign UDI and ensure traceability of distributed devices
• Verify registration of Manufacturers & Authorised Reps in EUDAMED
• Additional requirements if a device is modified before placed on the market

For Distributors:

• Verify device compliance
• Safeguard storage and transport conditions
• Reporting non conformities, complaints and incidents
• Cooperation with Competent Authorities
• Assign UDI and ensure traceability of distributed devices
• Additional requirements if a device is modified before placed on the market

Summing up, everyone in the supply chain has more to do and probably for the most, more than they initially thought.  There is little time left for each part to perfect its role, little time left for dress rehearsals, but all must be ready in time for opening night, come May 2022.

Invest time now in determining what part your business plays, what it needs to do and how it interacts with the other ‘actors’ in the supply chain.  Think what is at risk and get plans and control measures in place.

IMed consultants are here to help economic operators in the IVD supply chain, understand their responsibilities and provide a pathway to compliance.  If you would like to get in touch, please call us on 01295 724286 or email us at hello@imedconsultancy.com .