There are now four entities defined under the EU MDR and IVDR as “economic operators”. Under the new regulation, these entities will share the duty of ensuring compliance of the medical devices they manufacture, import and distribute for sale in the EU.What is a Med Tech Economic Operator?
- ‘‘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.’
- ‘’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.’
- ‘‘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.’
Medical device compliance responsibilities shared by EOs
While the compliance of a medical device has traditionally been the responsibility of its legal manufacturer, the EU MDR and IVDR will change all this. The new regulations define new legal responsibilities for all these ‘economic operators’ to understand and act on.
And even though the delay of the EU MDR and IVDR deadline to May 2021 gives all EO entities more time to become compliant there is still a lot to take in, and required actions that could result in some significant organisational change.
‘Joint and several liability’ for Economic Operators under the MDR and IVDR
The prospect of joint liability for quality failings by any of these EOs means all parties should be vigilant and proactive as they plan their response to the changes in regulation. Manufacturers are advised to begin mapping out their supply chains to identify each EO as defined in Article 2. This important step will help them in their efforts to assess and confirm the ability of everyone involved in the supply of their products to fulfil their responsibilities.
Manufacturers, AR and importers to register with EUDAMED
It should also be noted that under the new regulation, the manufacturer, authorised representatives, and importers must also prepare to be registered with EUDAMED (the European database on medical devices). As the launch of EUDAMED has also been delayed, exactly how this registration will work is still uncertain. However, it will be important to stay up-to-date with the guidance, as another method of registration may be provided.
Here are a few of the new responsibilities introduced by the MDR and IVDR that commentators are highlighting as particular challenges for some EOs
New Responsibilities for Importers
Under the MDR and IVDR Importers of medical devices have new responsibilities to meet specific regulatory requirements and verify certain information from the manufacturers they are working with.
Importers will have to carefully evaluate and verify whether legal manufacturers have the technical, scientific and financial capability to manufacture devices that are compliant with the regulation.
Additionally, they have a new legal obligation to take their own corrective action when they identify non-conformance and also engage in post-market surveillance activities in their own right.
These duties will be new to many importers and clearly may require additional resources with specific expertise for their implementation. As many have noted the level of responsibility these EOs now need to take surrounding the safety of end-users, including the appropriate tracking of complaints, may well require the introduction of a QMS to organise the necessary processes and procedures.
New Responsibilities for Distributors
For the first time, the new EU MDR introduces regulatory requirements for distributors to adhere to.
They must ensure required instructions for use are included with each device and that CE marks, Declaration of Conformity, and any required unique device identification marker are present on the device.
The distributor must demonstrate to the competent authorities that it has verified these requirements and is not relying on any other party’s commitments and declarations.
Distributors are required to act with due care and ensure storage or transport conditions comply with those set out by the manufacturer.
Similar to an importer, the distributor also has a new duty to capture and share customer complaints with key stakeholders in the chain and beyond.
According to the consultants ‘NAMSA’ - distributors have a significant new responsibility to:
“take all the necessary measures to prevent a medical device from being placed on the EU market, or even withdraw or recall it, should they have credible evidence that it does not comply with the requirements outlined in the EU MDR.”
Again, even if the regulation does not explicitly mention it, the need for distributors to develop a Quality Management System to properly document and implement these requirements is evident.
New Obligations for Authorized Representatives
Currently, manufacturers who are not resident within the EEA must designate an ‘Authorised Representative’ (AR), who is resident within the Community to be responsible for their product. Under the new MDR entities, ARs must register themselves in EUDAMED (or whatever registration system is adopted until EUDAMED is implemented).
After May 26, 2021, therefore, ARs will be made jointly liable for the devices, alongside the importer and manufacturer.
The Authorised Representatives’ obligations include:
- MDR/IVDR Article 11(3)(a): Verifying that the EU declaration of conformity and technical documentation has been drawn up and that an appropriate conformity assessment procedure has been carried out by the manufacturer
- MDR/IVDR Article 11(3)(b)). Keeping copies available of all documents and making them accessible to authorities on request. This includes technical documentation, declarations of conformity, and certificates, including their amendments and supplements
- EU (MDR/IVDR Article 11(5) The authorised representative will be liable for defective devices together with the manufacturer if the manufacturer has not complied with its obligations under the Regulations and is not located in the EU.
- (MDR/IVDR Article 15(6)) The authorised representative should have permanent and continuous access to a person responsible for regulatory compliance
This increase in regulatory and legal liability present new challenges for the role of Authorized Representatives. For many, it will require a significant organisational change and new agreements with manufacturers to accommodate the new requirements.
Many importers and distributors may not realise that under the new MDR and IVDR, they will be “jointly and severally liable” for the devices they help deliver to the market along with manufacturers and their Authorised Representatives.
Some of these new requirements will likely require many companies to implement a Quality Management System (QMS) for the first time to deliver on their obligations effectively and demonstrate they are doing so to their partners and their regulators.
The advice is that EOs should take advantage of the delay in the regulation’s implementation to ensure they have the appropriate agreements, systems and processes in place to tackle their new regulatory responsibilities.