On 28th. April 2022, Joytech got initial issuance of EU MDR for our non-invasive blood pressure monitors，you can find out the details here.
In 2023, Joytech contact thermometers, non contact thermometers and new blood pressure monitors are all EU MDR approved.
What is CE（MDR）?
When it comes to CE certificates, everyone is familiar with it. Almost every industry has a corresponding CE certification. MDR is the abbreviation of European Medical Device Regulation, which is the update of CE (MDD) and imposes higher requirements on the safety and performance of medical devices. We also call it CE（MDR）.
What are the differences between CE（MDD）and CE（MDR）?
MDR is a regulation and MDD is a directive. Because it is an upgrade, from directives to regulations, EU member states will exercise stricter control over the certification process and results.
Mainly reflected in the following aspects:
1) Strengthened the manufacturer’s responsibilities.
a) The manufacturer must have at least one compliance officer with expertise in the field of medical devices (there is no explicit requirement in the MDD directive);
b) The manufacturer shall establish and continuously update technical documentation and ensure that it is available when requested by the national competent authority.
c) Manufacturers must respond to unannounced inspections by notified bodies at any time to ensure the update of technical documents and maintenance of the system; (Class II products)
d) For high-risk products of trading companies, it will be more difficult to apply for CE.
2) Increased regulatory provisions and stricter certification review.
a) Increased classification rules: from 18 in MDD to 22 in MDR;
b) The basic requirements checklist items are increased: from 13 items in MDD to 23 items in MDR;
c) The structure of CE technical documents has changed and is divided into: product technical documents and post-marketing documents (MDD only requires product technical documents);
d) Clinical evaluation report. MDR requires companies to provide the fourth version of clinical evaluation reports, which is more stringent than the third version;
3) Expanded scope of application
a) MDD only targets products with medical purposes, while MDR includes some non-medical devices into the scope of application, such as vegetable contact lenses, beauty products, etc.;
b) In the MDD, reusable devices are classified as a class of medical devices and do not require the intervention of a notified body, while the MDR requires a notified body to conduct a conformity assessment of reusable surgical devices;
4) MDR requires greater transparency and traceability
a) Introduced the unique device identifier UDI to increase product traceability;
b) Relevant information of the company will be collected into the European Medical Device Database (EUDAMED);
c) Establish a post-market surveillance (PMS) system;
d) The notified body will conduct unannounced inspections.
What is the clinical evaluation of MDR CE?
The clinical practice we are talking about is generally divided into two forms:
a) Clinical trials are used on humans to obtain data to prove the safety of the product.
b) Clinical reports mainly prove the safety and effectiveness of the product through product comparison (from three aspects: clinical data, technical parameters, and biological performance), data analysis, and literature review.
c) The clinical evaluation report is part of the CE technical document and is also a key component (the clinical evaluation report is an indispensable report in the CE technical document when applying for CE certification).
d) Currently, the fourth version of the clinical evaluation report is implemented, which is a clinical evaluation report compiled in accordance with the clinical evaluation guideline MedDev 2.7.1.
Passing MDR certification means that Joytech blood pressure monitor and digital thermometer have reached strict standards in design, production and quality control, and can provide safer and more reliable medical devices to users around the world.
Joytech blood pressure monitor and digital thermometer have won unanimous praise from users for their accurate measurement results, user-friendly design and excellent performance. Now, they have passed the MDR certification, which will undoubtedly further enhance users' trust and satisfaction in our products.
Joytech Healthcare will continue to be committed to providing high-quality medical devices and contributing to the health of users around the world. We believe that through our efforts, our quality products will helpful to your healthy life in the global market.
If you have any questions or needs about our blood pressure monitor and thermometer products, please feel free to contact us.
