MDR Certification

Tenscare are proud to be MDR Certified.

MDR certification guarantees the highest level of quality,
safety, and effectiveness to our customers.

The new Medical Device Regulation came into force in May 2021.
Introduced to correct weaknesses in the old system in order to improve
patient safety, it is widely acknowledged to be one of the most rigorous
medical device controls in the world. (The MDR is 228 pages compared to
the 60 pages of the earlier MDD.)

TensCare have worked incredibly hard with our Notified Body BSI
Netherlands, our suppliers, and our European dealers to establish the
documentation, controls and clinical evidence needed in this ever more
complicated world.

 

A simplified version of the CE approval process in Europe.

 

Step 1.  To obtain CE Marking certification, you must comply with European Commission
Regulation (EU) No. 2017/745, commonly known as the Medical Device Regulation (MDR).

 

Step 2. Appoint a Person Responsible for regulatory compliance. Determine classification
of your device using Annex VIII (Classification Criteria) of the MDR - Class I (self-certified);
Class I (sterile, measuging or reusible surgical instrument); Class IIa, Class IIb, or Class III

 

Step 3. Implement a Quality Management System (QMS) in accordance with the MDR.
Most companies apply the EN ISO 13485 standard to achieve compliance. Your QMS must
include Clinical Evaluation, Post-Market Surveillance (PMS) and Post Market Clinical
Follow-up (PMCF) plans. Establish Quality Agreements with critical suppliers and make
arrangements with them about unannounced Notified Body audits.

 

Step 4. Prepare a CE Technical File providing information about your device and its
intended use plus testing reports, Clinical Evaluation Report (CER), risk management file,
IFU, labeling and more. Obtain a Unique Device Identifier (UDI) for your device. All devices,
even legacy products in use for decades, will require clinical data.
Most of these data should refer to the subject device.

 

Step 5. If you do not have a location in Europe, appoint an Authorized Representative (EC
REP) located in the EU who is qualified to handle regulatory issues. Place your EC REP name
and address on device label. Obtain a Single Registration Number from the regulators.

Establish Quality Agreements with Importers and Distributors in Europe.

 

Step 6. Your QMS and Technical File must be audited by a Notified Body, a third party
accredited by European authorities to audit medical device companies and products.

 

Step 7. You will be issued a European CE Marking Certificate for your device and an ISO
13485 certificate for your facility following successful completion of your Notified Body
audit. ISO 13485 certification must be renewed every year. CE Marking certificates are
typically valid for a maximum of 5 years, but are typically reviewed during your annual
surveillance audit.

 

Step 8. Prepare a Declaration of Conformity in accordance with Annex IV, a legally binding
document prepared by the manufacturer stating that the device is in compliance with the
applicable European requirements. You may now affix the CE Marking.

 

Step 9. Register the device and its Unique Device Identifier (UDI) in the EUDAMED database.
UDI must be on label and associated with the regulatory documents.

 

Step 10. You will be audited each year by a Notified Body to ensure ongoing compliance
with the MDR. Failure to pass the audit will invalidate your CE Marking certificate. You must
perform Clinical Evaluation, PMS, and PMCF activities to maintain certification.