Article 18 of MDR addresses the need for an implant card for implantable medical devices. For an Asian implantable devices manufacturer, fulfilling the requirements of EU MDR Article 18 without an EU Authorized Representative might not be possible.
What are the Requirements of EU MDR Article 18?
EU MDR Article 18 requires manufacturers of implantable devices to send an implant card enlisting all the essential information for the patients using implantable devices.
EU Authorized Representative and Article 18
An EU Authorized Representative can help Asian manufacturers fulfilling the requirements of MDR Article 18 in the following ways, i.e.,
- Provision of Implant Card
- Assisting in Providing the Relevant Information on the Implant Card
- Enlisting the Precautionary Measures
- Enlisting the expected lifetime of the device
- Helping in providing the information for the safe use of the device.
1. Assisting with Provision of the Implant Card to the User/Patient
An EU Authorized Representative can help Asian manufacturers provide the implant card to the users/patients as per the requirements of EU MDR Article 18. These requirements are
- Presenting the implant hard/physical copy
- Presenting the information on the implant card in a way that it can be easily understood by a layperson
- Updating the information according to the requirements.
2. Providing the Relevant Information on Implant Card
Without the help of an EU Authorized Representative, Asian manufacturers won’t provide the required information on the implant card correctly. This information will contain:
- Device Identification
- Device Name
- Serial Number
- Lot Number
- UDI
- Device Model
- Manufacturer’s name, address, and website.
3. Enlisting the Precautionary Measures
With EU Authorized Representative, Asian implantable medical device manufacturers can enlist the precautionary measures on the implant card according to the requirements. These are:
- Considering the reasonably foreseeable external influences
- Medical examinations
- Medical conditions.
4. Providing the Expected Life-Cycle of the Device
The EU Authorized Representative can help the Asian manufacturer provide the information of the expected life cycle of the device correctly.
5. Providing Information Regarding Safe-Use of The Device
With an EU Authorized Representative, the implant device manufacturer can show compliance to EU MDR’s Annex I, Section 23.4. The Point (u) of this section describes the provision of the necessary information to ensure the patient’s safe use of the device. The information provided on the Implant Card in this regard should also mention the quality and quantity of materials used in these implants, to which the patient can get exposed.
What are the Precautionary Measures to be Mentioned on the Implant Card?
The manufacturer must mention any warnings, precautions, or preventive measures taken by the patient or healthcare professional regarding reciprocal interference.
Which Asian Implantable Device Manufacturers are Exemoted from the MDR Article 18?
Clause 3 of Article 18 exempts the manufacturers of the following implantable medical devices from its requirements:
- Staples
- Sutures
- Dental Fillings
- Dental Braces
- Tooth Crowns
- Screws
- Wedges
- Plates
- Wire Pins
- Clips
- Connectors.
Looking for MDR Article 18 Compliance?
As an Asian medical device manufacturer, you will require to become compliant with Article 18 of the EU MDR. With our experts at TS Q and E, we have been helping many Asian medical devices and implantable device manufacturers comply with EU MDR’s Article 18. Contact us at any time to get the consultancy from our experts at TSQ Asia to get your MDR Article 18 compliance now.