What has changed?
The new regulation imposes more and stricter demands on medical devices, and on the manufacturers who produce or sell medical devices.
- Before you are permitted to market medical devices in risk classes IIa, IIb, III and IVD B, C, D, you must first have them tested and approved by Notified Bodies.
- You are allowed to approve products from classes I and A yourself.
- Also, you have to keep conducting active research into your products for as long as they are on the market, using stricter rules.
Demands
You are only permitted to market your product once it meets all legal demands. You will have to meet the following stricter demands.
Re-evaluate your product’s risk class
The risk classes have changed. Does your product still fall into the same risk class? You may have to assemble supplementary clinical evidence for your product, or have it evaluated by a Notified Body. The medical regulation states four classes: I, IIa, IIb, and III. Product class I represents the lowest risk, III the highest. Check your product’s risk class in the MDR (Annex VIII).
You can place risk class I products on the market, if they comply with the new MDR and IVDR. You have to register your device and company in EUDAMED, the database for European medical devices.
If your medical device is deemed a class II or III device, you can register it with the Notified Body that has performed the risk assessment. Find a list of Notified Bodies on the EU NANDO website.
Read the general safety and performance requirements
The general safety and performance requirements on amongst other things labelling, technical documentation and the quality management system have been made stricter. You will find them in Annex I of the MDR and the IVDR.
Use a unique identification code (UDI)
Make sure your product is fitted with a unique device identifier code (UDI). This unique barcode ensures that it is always clear straight away which medical device a patient is using.
Meet the stricter demands on clinical evaluation
To make sure your medical device is safe and effective for patients, you need to perform a clinical evaluation. Make sure you meet the stricter demands. You will find these in Annex XIV of the MDR.
Appoint persons responsible for regulatory compliance
Make one or more persons (depending on the size of your company) responsible for making sure the company complies with the regulations.
Provide sufficient financial back up
Ensure you have the financial means to deal with a liability complaint because of a faulty product.
Perform Post Market Surveillance
To chart the experiences with your product, you have to do market research: Post Market Surveillance. You do not just record complaints and notifications, you actively request data from the persons using your product. Your reports must meet certain standards. You can find these in sections 1 and 2 of chapter VII of the MDR.
Install a reporting system for incidents
Be sure to have a system for reporting incidents involving your product and describing your field safety corrective actions.
Draw up a Periodic Safety Update Report
You have to draft a Periodic Safety Update Report for your product.
If your company is not located in the EU, you must appoint an authorised representative to deal with the legal obligations within the EU.
Stricter rules for authorised representatives
There are also stricter rules for authorised representatives.
- Your authorised representative has to register in EUDAMED and keep their listing up-to-date.
- Your authorised representative has to make sure you have drafted the EU conformity declaration and technical documentation.
- They have to make sure that a notified body has evaluated the medical device, if it is required for this device.
- Also, your authorised representative has to report complaints and notifications about medical devices, and give information to the competent authority, such as the Health and Youth Care Inspectorate. Find more information on the role of the authorised representative in article 11 of the MDR.
A major change in the new rules is that you, the importer and the authorised representative are jointly and severally liable. You have to record your arrangements for this in a mandate between you, the importer and the authorised representative.
Extra demands for IVD manufacturers
Do you manufacture an in vitro diagnostic medical device (IVD)? Then, in addition to everything mentioned so far, you will have to take into account the following points.
Have your IVDs evaluated
Most IVDs have to be evaluated by a notified body, according to the classification rules. You will find these in appendix VIII of the IVDR.
Provide clinical evidence that you meet the product requirements
To prove your product meets the requirements, you must present clinical evidence.
Ask advice for devices for companion diagnostics
If you manufacture medical devices for companion diagnostics, you will have to deal with a new consultation procedure. This procedure is still in the preparatory phase.
New appointment of notified bodies
The new regulations state that the EU member states have to re-appoint all notified bodies. You cannot have your product evaluated under the new rules until the member state has re-appointed your notified body.