Congratulation! Unimed Obtains MDR Notification Certificate

We are pleased to announce that Unimed Medical Supplies Inc. successfully passed review of the EU authorized representative, and obtained MDR Notification Certificate, REF. NO.:LCA 1041-2021.

Unimed Class I devices are fulfilling the applicable requirements of the MDR compliance and have the qualification to continue to place these devices on the market of European Union and EEA territory after the full implementation of the MDR on May 26, 2021. (Please see attached list for Unimed 14 Class I devices)

For Unimed Class IIa and Class IIb medical devices, until May 2024, products which have been certified under MDD can under certain conditions still be placed on the market after the MDR fully applies, as long as the EC certificate are valid. Accordingly, Unimed will continue to place MDD certified medical devices no the market during this period, until the certificate expires (June 8, 2023). At the same time,we are carrying out the MDR certification of Class II devices, including SpO2 Sensors and temperature probes.

The Class I Medical devices from Unimed Medical:

Catalogue reference number	Commercial Name
U18XX series, U18XXN series	Reusable NIBP Cuff
U17XX series, U16XX series	Disposable NIBP Cuff
AA series, AD series, AP series, AT series, BK series, BN series, CL series, D series, DG series, DT series, DX series, E series, FD series, FK series, HP series, HT series, LL series, LM series MD series, MN series, MQ series, MR series, MT series, MV series, NE series, NK series, PT series, PW series, QT series, SL series, SM series, TM series, WA series, X series, 2XXX series	ECG Cables & Lead Wires
DS series, DP series	Disposable ECG Lead Wires
UU series, AD series	EKG accessories
BC series	IBP Adaptor Cable
U7XX series	Reusable SpO2 Adaptor/Extension Cable
TXXX-AD series, TXXX-PH series	Temperature Adaptor/Extension Cable
HS series, HD series	NIBP Air Hoses
BP series	NIBP Connectors
E023, E024, E025, T002, Y04-E019, Y04-E041, UEC-01	SpO2 accessories
E043, E044	Fetal Transducer Belts
U-EEG series	Disposable Non- invasive EEG Sensor
HPI series, PI series,DPI series	Pressure infuser

 

What is MDR

The European Medical Device Regulation (EU MDR) is an upgrade of MDD. It dedicates to ensures high standards of quality and safety for medical devices being produced in or supplied into Europe.

What changes are for MDR?

The changes from MDD to MDR are mainly reflected in the following aspects:

1) Strengthen the responsibility of the manufacturer:

1. The manufacturer must have at least one compliance officer with expertise in the medical device field (there is no obvious requirement in the MDD directive).
2. The manufacturer shall establish and continuously update technical documents and provide them to national authority when required.
3. The manufacturer should always respond to the unannounced inspection by the notified body to ensure the update of technical documents and the maintenance of the system(Class II products).
4. It will be more difficult for trading companies to apply for CE.

2) Increased regulatory provisions and stricter certification review

• Increased classification rules, the MDD has only 18, and MDR has 22.
• The basic requirements checklist items are increased to 23 for MDR.
• The CE technical document is divided into product-technical documents and post-marketing documents (MDD only requires product-technical documents).
• Clinical evaluation report. MDR requires companies to provide the fourth edition of the clinical evaluation report, which is more stringent than the third edition;

3) Expansion of the scope of application

• MDD is only for products with medical purposes. MDR includes some non-medical devices, such as dish-colored contact lenses, beauty products, etc.
• In the MDD, reusable devices are class I devices, which do not require the intervention of the notified body, while the MDR requires the notified body to conduct conformity assessment of repetitive surgical instruments.

4) MDR requires higher transparency and traceability

• The MDR introduced the unique device identification UDI to increase the traceability of products.
• The company information will be added to the European Medical Device Database (EUDAMED).
• Establish a post-marketing supervision (PMS) system;
• Notifying agencies will conduct unannounced inspections.

Both equipment and manufacturers must comply with MDR. You should assess the compliance of the equipment-this may require the involvement of a notified body.

Other highlights include:

• Clinical evaluation
• Risk Management
• Quality Management System (QMS)
• Post-listing supervision
• Technical documents and other reports
• Liability for defective equipment