EN
Importation of rehabilitation equipment and home care machines to the European Union can be quite difficult, especially when dealing with such strict regulations of medical devices. In the case of distributors and care providers, picking the right manufacturer in terms of certificates will ensure the safety of the product, entrance to the market, and the reputation of the products amid the customers. Being an ISO 13485:2016 and CE-MDR certified producer, Zhongshan Kandebao (KDB) Rehabilitation Equipment Co., Ltd. clarifies the following essential certifications needed to import products to the EU.
1. CE Marking Under MDR (EU) 2017/745
In the EU, the CE mark is compulsory on the sale of medical devices. Starting in May 2021, the new Medical Device Regulation (MDR) 2017/745 superseded the older MDD (Medical Device Directive) with more stringent safety, performance and post-market surveillance demands.
Class I, (non-sterile Nx measuring) self-déclarable (e.g., basic shower chairs, walks).
Class IIa/IIb (high risk): Needs to go through Notified Body's assessment (e.g. lifts for the patients, the powered aids for mobility).
There are no problems with entering the EU market also because KDB products that are certified as CE-MDR (e.g., patient lifts, commode chairs) satisfy these standards.
2. ISO 13485:2016 (Medical Device QMS)
This quality management standard guarantees that manufacturers adopt uniform production, risk management and tracking procedures. EU officials and consumers would give preference to the suppliers holding this certification.
KDB has the ISO 13485: 2016 certificate, and this ensures robust quality control both in R and D and delivery of products.
3. Additional Certifications for Specific Markets
TUV Certification: It is very common that German buyers regularly request TUV Certification to get an added measure of safety.
UKCA Marking: Required on the UK market since Brexit (the same as CE).
EN Standards: its credibility is enhanced by compliance with EN 12182 (assistive products) or EN ISO 14971 (risk management).
KDB provides supportive documentation that suits the needs of the various countries in the EU.
4. Post-Market Surveillance and Technical Documentation
EU MDR requires:
Detailed technical files (design, materials, biocompatibility).
Clinical reviews (in the case of upper-class devices).
The monitoring of long-term safety is done through post-market surveillance (PMS) reports.
KDB fulfills all these requirements completely and minimizes the regulatory risks of buyers.
Why Partner with KDB?
We are a certified producer of rehab and elderly care equipment and assist the EU importers on labyrinthine regulations with:
Production CE-MDR / ISO 13485 certified
Certified TUV designs, patented more
Distributor custom designed compliance assistance
Reach us with compliant and quality rehab equipment!