You are a medical device manufacturer and have CE marked your products under the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD)? Then you must transition to the IVDR in the future to keep your products on the European market. Below you will find a brief synopsis of the 11 most important changes including links to guidance and templates.
1. Shift from pre-approval to a life-cycle approach
The IVDR promotes a shift from pre-approval to a life-cycle approach. Risk management and the connected processes on PMS and performance evaluation must be conducted continuously throughout the product’s life cycle.
2. Classification changes
Contrary to the list-based system under the IVDD, the IVDR provides for a risk based classification system with classes from A to D (A being the lowest and D the highest risk class).
Please see here for an overview of the IVDR classification rules.
The IVDR brings a stronger supervision of manufacturers by Notified Bodies. Manufacturers of all risk classes except for class A will require a Notified Body certificate to CE mark their products. An estimated 80-90% of manufacturers will thus be required to take this step whereas it was necessary only for 10-20% of companies under the IVDD. This is clearly one of the most dramatic changes for the industry.
Please also read our article “Notified Body Selection and Change”.
You are welcome to contact us should you require our support to identify your Notified Body.
4. Clearer rights and responsibilities for economic operators
With the IVDR roles of economic operators (manufacturer, authorized representative, distributor, importer) have been narrowly defined. Each economic operator must ensure that the corresponding role is fully understood and agreements are set up accordingly.
Please see here for the factsheets issued by the European Commission.
5. Traceability / EUDAMED
The IVDR requires manufacturers of all classes to implement a UDI system for enhanced traceability. UDI components will also be used for the registration in the new upgraded EUDAMED database. EUDAMED will replace national registries that have been operated under the IVDD.
For guidance issued by the European Commission on these topics, please visit its website.
6. The new General Safety and Performance Requirements
The new General Safety and Performance Requirements (SPR) will replace the Essential Requirements (ER). The SPR are much more comprehensive than the former ER and also bring new or amended requirements, e.g. on labeling. In addition, manufacturers are required to complete the corresponding checklist in much more detail.
You find a preview of a SPR checklist in our Supportive Information Section for the IVDR.
7. Performance evaluation and clinical evidence
The IVDR narrowly defines the performance evaluation, a continuous process that is intended to provide sufficient clinical evidence to demonstrate that the intended clinical benefits will be achieved and that the device is safe. mdi Europa has set up a template that will guide you through the entire process.
You find a preview of the performance evaluation template in our Supportive Information Section for the IVDR.
8. Technical file structure
Annex II and III of the IVDR provide details about the required contents of a technical file. Notified Bodies and competent authorities made clear that they expect manufacturer’s documentation to be prepared readily searchable and in line with the revised structure.
You find a preview of technical file checklists in our Supportive Information Section for the IVDR.
9. Person Responsible for Regulatory Compliance
Manufacturers must employ a person in their organization who is in charge of the company’s regulatory compliance. This person has to possess a defined set of qualifications or experience respectively.
Please see here for the corresponding guidance document.
Manufacturers are required to provide sufficient financial coverage for potential liability claims. The EU Authorized Representative will become liable for the manufacturer’s products as well.
11. Own Brand Labeling (OBL)
The concept of OBL will be obsolete under the MDR as there will no more difference between the Original Equipment Manufacturer (OEM) and the OBL company.
We recommend our article OEM – Private Labeling.