The new EU Medical Device and In Vitro Diagnostic Device regulations were approved by the European Parliament in May 2017. One aspect of the new legislation is the definition of an Economic Operator. This definition impacts a number of organisations involved in the supply of medical devices and the clarification of the obligations of each of these Economic Operators.
The new regulations are the biggest change to the legislative framework for MD and IVD products in decades. The impact on device manufacturers and other Economic Operators is significant, with new or changed requirements across the entire product lifecycle. Companies will need to implement many new or enhanced capabilities to meet these obligations.
Who are the organisations that are classed as Economic Operators?
Article 2 of the new regulations define an Economic Operator as:
‘A manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3)’
Article 2 then defines these four groups of organisations as:
‘‘Manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.’
‘‘Authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation.’
‘’Importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market.’
‘’Distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.’
Obligations of Economic Operators
Chapter 2 of the regulations includes a series of articles that detail the general obligations of:
- Manufacturers (Article 10)
- Authorised Representatives (Article 11)
- Importers (Article 13)
- Distributors (Article 14)
These articles set out, in a series of statements, the expectations of each of these Economic Operators with regard to the regulations. Organisations need to review these statements to determine if they, and their partners, will be in compliance with the new regulations, or if new or enhanced capabilities will be required.
Other types of Manufacturer
There are some further sub-categories defined within the scope of ‘Manufacturer’ over and above the traditional device manufacturer:
- Repackaging activities undertaken by Importers and Distributors (Article 16)
- Reprocessing of single use devices (Article 17)
- Providers of systems and Procedure packs (Article 22)
- Parts suppliers (Article 23)
Dependent upon the specific activities being executed by suppliers of any of the above, they could be subject to some or all of the obligations of manufacturers. To be compliant it is important to understand how your operations are affected by these requirements and what further actions you may need to take.
What do I need to do from here?
From the above it can be seen that companies will have to review the general obligation statements in relevant articles against their operations. The first step is likely to be a gap analysis of the requirements including:
- Understand the general obligation statements from relevant articles in the new regulations.
- A gap analysis of each relevant aspect of the company’s operations against these statements.
- Initial high level designs of potential new processes, capabilities and IT solutions.
- High level roadmap for implementing new processes, capabilities and IT solutions.
- Cost and resource impact estimation.
- Plan for the next phase of activity.
This will then allow you to resource and execute the updates required.
It is important to consider the impacts on partner organisations as well as your own. Are there significant changes that they may need to make that can put supply of your products to customers at risk? May you need to change some suppliers to ensure your value chains remain compliant?
As can be seen from the above, it is essential to ensure you meet the general obligations from relevant articles in the new regulations. This needs to be a holistic approach considering which articles impact your operations and also where there are impacts on external partners. A detailed assessment and action plan will help ensure a successful outcome for your organisation.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April on Medical Devices
Be4ward has many years of experience in delivering large and complex legislative-driven change. We have written this document to capture some of our learning throughout that journey and hope it will be useful to you, the reader.
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