You are a medical device manufacturer and have CE marked your products under the Medical Devices Directive 93/42/EEC (MDD) or the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)? Then you must transition to the MDR in the future to keep your products on the European market. Below you will find a brief synopsis of the 12 most important changes including links to guidance and templates.
1. Shift from pre-approval to a life-cycle approach
The MDR promotes a shift from pre-approval to a life-cycle approach. Risk management and the connected processes on PMS and clinical evaluation must be conducted continuously throughout the product’s life cycle.
2. Classification changes
As mentioned above, some classification rules are new or amended while others remain unchanged.
Please see here for an overview of the MDR classification rules.
3. Change in conformity assessment rules
The annex structure of the MDR is different compared to the MDD. Manufacturers must make sure that they choose the appropriate conformity assessment procedure.
Please see here for an overview of the MDR conformity assessment routes.
The MDR brings a stronger supervision of Notified Bodies by national authorities. Notified Bodies in turn will gain more powers to scrutinize manufacturers. In general, manufacturers of all classes of devices must prepare themselves for tighter control.
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.
5. Clearer rights and responsibilities for economic operators
With the MDR 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 visit our Download Section for the factsheets issued by the European Commission.
6. Traceability/ EUDAMED
The MDR 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 MDD.
For guidance issued by the European Commission on these topics, please visit its website.
7. General Safety and Performance Requirements (SPR)
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 requirements, e.g. on software 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 MDR.
8. Clinical evidence
The expectations for clinical evaluations under the MDR have been synchronized for the biggest part with what has already been formulated in the MEDDEV 2.7/1, rev. 4 guidance document. This also means that it will generally be more difficult for manufacturers to claim equivalence with another device. As a result, manufacturers should consider generating their own clinical data to provide sufficient clinical evidence.
Please see here for the corresponding MEDDEV document
and our template for clinical evaluations.
9. Technical File structure
Annex II and III of the MDR 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 MDR.
10. 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.
12. 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.