ANSWERED ON THIS PAGE:
- What is the medical device classification scheme in Europe?
- How can we determine the classification of our medical device?
- How will the new Medical Device Regulation affect classification?
Before medical device manufacturers can legally CE mark their products in Europe, they must comply with the appropriate medical device directive or regulation set forth by the EU Commission. It is vitally important to know the correct medical device classification for your product before CE marking your device. Classification impacts the regulatory requirements for your device, as well as the approval route and its associated costs.
Determining your device classification for Europe
The first step in the European regulatory process is to determine the classification of the device under Medical Device Regulation (MDR) No. 2017/745 for medical devices or active implantable medical devices, or In Vitro Diagnostic Device Regulation (IVDR) No. 2017/746 for IVD devices. Note that the MDR also includes products specifically delineated in Annex XVI that do not have a medical purpose.
Europe uses a rule-based classification scheme for medical devices. There are now 22 rules in Annex VIII of the MDR. The level of regulatory control and the requirements for compliance to the MDR increase with the risk level associated with the finished medical device. The European system stands in contrast to the U.S. system, which largely depends on finding similar devices (predicates) already cleared by the FDA.
How medical devices are segmented in Europe
Essentially, all devices fall into four basic categories:
- Non-invasive devices
- Invasive medical devices
- Active medical devices
- Special Rules (including contraceptive, disinfectant, and radiological diagnostic medical devices)
The MDR has a few additional special rules, including one for nanomaterials.
Devices are further segmented into the classes noted below. IVDs have their own classification scheme and while active implantable devices do not follow the same classification system as provided by the MDD, they are subject to similar requirements as Class III devices (the MDR includes active implantable medical devices):
- Class I – Provided non-sterile or do not have a measuring function (low risk)
- Class I – Provided sterile and/or have a measuring function (low/medium risk); the MDR adds to this group, reusable surgical instruments as Class I reusable surgical instruments.
- Class IIa (medium risk)
- Class IIb (medium/high risk)
- Class III (high risk)
We will work with you to classify your devices according to the MDR
Emergo represents more than 1,000 medical device companies as an Authorized Representative in Europe, and we have helped countless manufacturers obtain CE Marking. Our expert consultants throughout Europe have experience classifying a range of medical technologies, including novel and innovative devices. Here's how we can help:
- Our team specializes in medical device regulatory consulting and can help you determine the proper classification for your medical device to the MDR, or IVD device to the IVDR.
- Our in-depth knowledge of European medical device regulations ensures that we can assist you in finding the most efficient regulatory approval strategy for your device. We are also gaining significant experience with the MDR.
- We can assist you in preparing a Technical Documentation File that demonstrates compliance with the MDR or IVDR.
- As your Authorized Representative, we can communicate with Competent Authorities on your behalf once your device has been approved.
We have offices across Europe to help with medical device classification or regulatory strategy.
Will the new Medical Device Regulation (MDR) affect classification rules in Europe?
The MDR will revise classification rules and conformity requirements for specific products, such as some class II implants and substance-based devices. For more information about MDR and IVDR changes, download our white paper.
Will the IVDR revise classification rules for IVDs?
Yes. The IVDR will overhaul the classification system and requirements for IVDs. IVD companies can also expect Notified Bodies to be more involved in the regulatory process.
What is the date of compliance for Class I reusable surgical instruments?
According to the MDR, to continue to market the product in the EU, Class I reusable surgical instruments require a Notified Body issued CE marking certificate after 26 May 2021.