The New EU: IVDR (In Vitro Diagnostic Medical Devices Regulation) and Economic Operators
Mike Andrews, Ph.D., Vice President Regulatory and Quality, Boulder iQ, Boulder, Colorado
The EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will replace the EU In Vitro Diagnostic Medical Devices Directive 98/79 (IVDD). Compliance with the IVDR is required no later than May 26, 2022. The IVDR introduces some new terms, some new players, and assigns obligations beyond those found in the IVDD to some existing players. The main new term in the IVDR is Economic Operator (EO). This term refers to EU Authorized Representatives (AR’s), importers, distributors, and manufacturers, who are all required to register as EO’s in the EUDAMED database. We will explore in more detail the requirements for AR’s, importers, and distributors.
The IVDR adds a number of responsibilities for the AR. The most significant new responsibilities are as follows:
- The AR must have a written mandate for designation (previously it was “explicitly designated”)
- The AR must immediately terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
- An authorized representative who terminates must immediately inform the competent authority of the Member State in which it is established and the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons for the termination.
- The AR’s are now jointly liable for defective devices if the manufacturer is not carrying out its obligations under the IVDR.
- The AR must maintain records for 10 years after the last device has been distributed. It was previously 5 years after the last device had been manufactured.
- The AR may request a Certificate of Free Sale on behalf of the manufacturer.
This means that the contract between the manufacturer and the AR will have to be carefully drafted so that it includes all of the AR’s responsibilities under the IVDR. And the AR now has a role in maintaining compliance with the IVDR.
Importers were not even mentioned in the IVDD. Thus, their responsibilities are all new. The most significant new responsibilities are as follows:
- Before making a device available on the market, the importer must verify that:
- the device has been CE marked and that the Declaration of Conformity for the device has been drawn up;
- a manufacturer is identified and that an authorized representative has been designated by the manufacturer;
- the device is labelled in accordance with this Regulation and accompanied by the required instructions for use; and
- where applicable, a UDI has been assigned by the manufacturer
- If an importer believes that a device is not in conformity with the requirements of this Regulation, the device is not to be placed on the market until it has been brought into conformity. The manufacturer and the manufacturer’s authorized representative are to be informed. If the importer believes that the device presents a serious risk or is a falsified device, the Competent Authority of the Member State in which the importer is established is to be informed, and if applicable, the notified body that issued a certificate for the device in question.
If the device has been placed on the market, the importer would have the responsibilities described above.
- Importers are to keep a copy of the Declaration of Conformity and, if applicable, a copy of the relevant certificate
As in the case of the AR, the contract between the manufacturer and the importer will have to be carefully drafted so that it includes all of the importer’s responsibilities. The importer, like the AR, now has a role in maintaining compliance.
Like the Importer, the Distributor was not even mentioned in the IVDD. Thus, all of the responsibilities under the IVDR are new. The most significant new responsibilities are as follows:
- Before making a device available on the market, verify that:
- the device has been CE marked and the Declaration of Conformity of the device has been drawn up;
- the device is accompanied by the information to be supplied by the manufacturer in accordance with the IVDR; and
- where applicable, a UDI has been assigned by the manufacturer.
- If a distributor believes that a device is not in conformity with the requirements of the IVDR, the device is not to be made available on the market until it has been brought into conformity. The distributor must inform the manufacturer and, where applicable, the Authorized Representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established and, if applicable, the notified body that issued a certificate for the device in question.
If the distributor has already placed the device on the market, the distributor would have the responsibilities described above.
- As in the case of the AR and the importer, the contract between the manufacturer and the distributor will have to be carefully drafted so that it addresses all the distributor’s responsibilities.
Person Responsible for Regulatory Compliance
Though not an Economic Operator, the requirement for a person Responsible for Regulatory Compliance impacts the Manufacturer and the AR. Both must now identify a Person Responsible for Regulatory Compliance within their organizations. This responsibility may be shared by more than one individual. A micro or small enterprise does not have to have this person on staff but may contract for the position. The name, work address, and contact details of the person or persons responsible for regulatory compliance must be part of the information provided when the manufacturer or authorized representative register.
This Person must have certain expertise in the field of in vitro diagnostic medical devices. That expertise must be demonstrated by either:
- a diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices; or
- four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.
Responsibilities of the Person Responsible for Regulatory Compliance within the manufacturer’s organization include:
- checking the conformity of the devices, in accordance with the quality management system, before a device is released;
- assuring that the Technical Documentation and the Declaration of Conformity are drawn up and kept up to date;
- assuring that the post-market surveillance obligations in the IVDR are complied with;
- assuring that the vigilance reporting obligations referred to in the IVDR are fulfilled
Under the IVDR, EOs have responsibilities for traceability. Distributors and importers must cooperate with manufacturers or ARs with respect to the traceability of devices. An EO must be able to identify any EO they have directly supplied with a device, any EO that has directly supplied them with a device, and any health institution or healthcare professional they have directly supplied with a device. These distribution records must be maintained for 10 years after the last device has been placed on the market.
Several organizations and individuals are going to need to look very carefully at the details of the IVDR and prepare for the May 26, 2022 deadline. Importers and distributors are now in the spotlight with a series of brand-new responsibilities. The Person Responsible for Regulatory Compliance has his or her own set of responsibilities and all the Economic Operators have requirements with respect to traceability. As companies prepare for the new IVDR, they will need to think how the new requirements for Economic Operators affect their business and products.