Medical Devices Categorization in Europe
Medical Devices are categorized in the European Union in 4 classes: Class I, Class IIa, Class IIb and Class III. Class I being the lowest risk ones and Class III the highest risk ones.
There are also 3 “subclasses” in the Class I category:
- Class I provided in sterilized condition (Cl Is) are simple devices but which have been sterilized by the manufacturer, such as a vaginal speculum
- Class I with a measuring function (Cl Im), such as graduated urine bags/recipients
- Class I reusable (Cl Ir) are reusable surgical instruments such as surgical scissors or forceps used in surgical procedures and reused many times after proper local cleaning and sterilization.
All medical device classes require the involvement of a notified body for their conformity assessment, except the Class I not sterilized, without a measuring function, and which are not reusable surgical instruments. Such devices are for example corrective eyeglasses or orthoses or crutches.
Class I Medical Devices, CE Mark and the 4-Digit Number
These medical devices will bear the CE mark without any following number while those requiring a notified body intervention will bear a 4-digit number corresponding to the Notified Body number.
However, does it mean manufacturers of such low-risk Class I devices have nothing to do to comply with the new Regulation? Of course not!
These rules have been clarified by the Medical Device Coordination Group in the document MDCG 2019-15 rev. 1 and in the below summary. Class I devise manufacturers must have almost the same technical documentation and must apply similar attention to the production of these devices than the higher-risk device manufacturers.
In fact, the principles are not different than the former Medical Device Directive (MDD) but, since the EU law has changed, manufacturers should update their Technical Documentation and their Quality Management System to comply with the new Medical Device Regulation (EU) 2017/745.
Condition to Place a Device on the EU Market
Therefore, before drawing up a new EU Declaration of Conformity (DoC) to the MDR and placing a device on the market, the manufacturer must complete several tasks:
- Confirm the product is a medical device and confirm its classification because the classification rules have changed
- Put in place a Quality Management System (ISO 13485) preferably certified by an accreditation body or a notified body
- Conduct a Clinical Evaluation
- Assess the device conformity in a Technical Documentation which means:Comply to the General Safety and Performance Requirements (GSPRs)
- Perform a Risk Analysis and put in place a risk management system
- Update the Biological Safety Evaluation Report as applicable standards have recently changed dramatically
- Keep this Technical Documentation up to date
- Prepare all the required information to accompany the device. For existing products, the IFU and the labels will have to be revised to reflect all the newly requested changes (Article 23 of Annex I) and in all languages where the device is made available
- Implement a Post-Market Surveillance to be integrated in its QMS based on the plan set forth
- Implement a vigilance report and registration system
- Register themselves in the EUDAMED database as an Economic Operator
- Assign a UDI to the device and its packaging by 26 May 2025
- Designate a Person Responsible for Regulatory Compliance meeting the article 15 qualification requirements
- For non-EU manufacturer sign a contract with an Authorized Representative located in an EU Member State
When should manufacturers comply with this Regulation?
For Class I devices for which classification has not changed, before 26 May 2021. For devices for which the classification has changed and for which a Declaration of Conformity has been drawn up according to the former Medical Device Directive before 26 May 2021 and require the intervention of a Notified Body, manufacturers must comply to the above points before 26 May 2024.
In addition, for these devices with a valid MDD certificate and which benefit from the grace period, , some of the requirements are applicable immediately: the post-market surveillance, the vigilance reporting and registration and a freeze of the device with no significant change.
The full MDR requirements are also compulsory since 26 May 2021 for Class I devices which are newly placed on the EU market.
One may be surprised about this date, but as a reminder, the regulation was published in April 2017 and was discussed for several years before 2017 so it should not come as a surprise to any Medical Device manufacturer.
Does it mean manufacturers can wait 2 more years without taking any action before 2024? Of course not, because getting ready for this new regulation takes quite a lot of time and effort.