Knowledge centre

Clinical Resources

Everything your practice needs — regulatory documents, product guides, safety data sheets, and expert clinical guidance.

Request product documentation

EU MDR Declarations of Conformity, Instructions for Use (IFUs), safety data sheets, batch certificates, and ISO 13485 certificates are available on request for any product in our catalogue. Because these are controlled documents, we issue the current, verified version directly — tell us what you need and our regulatory team will send it, typically within one business day.

Documentation desk

Which documents do you need?

Include the product name or SKU and the document type. B2B account holders can also request documents directly through the client portal.

✉ compliance@superiormedical.eu
⏱ Response within 1 business day

Regulatory compliance

Superior Medical maintains full compliance with EU MDR 2017/745 and associated harmonised standards.

EU MDR 2017/745
Medical Device Regulation
All products placed on the EU market comply with EU MDR 2017/745, with full technical documentation, post-market surveillance, and clinical evaluation.
  • Technical documentation maintained per Annex II/III
  • Periodic Safety Update Reports (PSUR) filed annually
  • Unique Device Identification (UDI) compliant
  • EUDAMED registered
ISO 13485:2016
Quality Management System
Our QMS is certified to ISO 13485:2016, covering design, manufacture, distribution, and servicing of medical devices.
  • Full scope certification (design through distribution)
  • Annual internal and external audits
  • Supplier qualification programme
  • Certificate valid to December 2027
Vigilance
Post-Market Surveillance
We operate a proactive PMS programme to monitor product performance, collect field data, and respond to any safety signals.
  • Incident reporting per EU MDR Article 87
  • Field safety corrective actions (FSCA) tracked
  • Complaint handling SLA: 48-hour initial response
GDPR
Data Protection
We process personal data lawfully under GDPR (EU) 2016/679, with appropriate technical and organisational safeguards.
  • Data minimisation by design
  • DPA registered (Portugal CNPD)
  • Data breach response within 72 hours

Frequently asked questions

Clinical and operational questions — answered by our expert team.

Yes. Every product sold by Superior Medical holds a valid CE mark under EU MDR 2017/745. EU Declarations of Conformity and technical documentation are available for download in the Documents tab, or on request from your account manager.
Absolutely. B2B account holders can request IFUs, SDS, batch certificates, and Declarations of Conformity for any product via the portal, or by contacting our compliance team directly at compliance@superiormedical.eu.
Standard delivery within mainland Portugal is 1–3 business days. EU deliveries typically take 3–5 business days depending on destination. Express and same-day options available in Lisbon for B2B clients — contact your account manager.
Yes. B2B accounts receive tiered pricing starting from 10 units. For high-volume procurement (100+ units), our team will work with you on a custom pricing agreement. Open a B2B account or contact sales@superiormedical.eu.
Unopened, non-sterile products may be returned within 30 days. Sterile or opened products cannot be returned for patient safety reasons, unless the item is defective. Contact returns@superiormedical.eu with your order number.
Most Women's Health products — including breast pumps, maternity TENS units, and postpartum care items — are available direct to consumers without a prescription. A small number of Class IIa devices are recommended for use under professional guidance.
Get in touch

Speak to our clinical team

Our team includes clinicians, regulatory specialists, and procurement consultants. We're here to help — whether you need a compliance document or product recommendation.

✉ info@superiormedical.eu
☎ +351 910 884 629
⏱ Mon–Fri, 9h–18h (WET)