Medical Devices- CE Marking

We at QVC in cooperation with it’s alliance partner Institute for Testing and Certification (ITC) a.s. Zlin, NOTIFIED BODY NO. 1023 provide Services in connection with conformity assessment of medical devices.

Any medical device may be introduced to the EU market only provided that an assessment of the conformity of its characteristics with the requirements laid down by Council Directive 93/42/EEC has been carried out and that the outcome of this assessment is the finding that the medical device meets the basic requirements, has been provided – except for specified exceptions – with the CE marking, satisfies the additional relevant requirements (e.g. information concerning its usage) and that the manufacturer or authorised representative has issued a written EC declaration of conformity to this effect. Institute for testing and certification is a member of TEAM-NB and is a signature of an ethics code (Code of Conduct).

Services provided in connection with conformity assessment of medical devices

  • Conformity assessment by ITC as Notified Body no. 1023 according to the requirements of the Council Directive 93/42/EEC, laying down the technical requirements for medical devices
    • The Applicant shall select a method of conformity assessment according to the classification of the medical device:
      • quality system assessment by the Notified Body (total quality assurance system)
      • assessment of production quality management system
      • assessment of product quality management system
  • Testing in the Accredited Laboratory
  • Granting licenses for voluntary certification mark

ITC grants a license for the use of the quality mark, which is granted to the products where high standard of safety and quality parameters has been proved by certification and where meeting the prerequisites of the producer for continuous quality compliance has been proved through inspection visits.

  • Certification of management systems (ISO 13485, ISO 9001, ISO 14001, OHSAS 18001)

Products List assessed in ITC according to the Council Directive 93/42/EEC

Products Limitations
*MD 0100 – General non-active, non-implantable medical devices
– *MD 0101 – Non-active devices for anaesthesia, emergency and intensive care Limited to devices of Classes Im, Is, IIa, IIb plus balloon catheters plus stent delivery systems
– *MD 0102 – Non-active devices for injection, infusion, transfusion and dialysis Limited to devices of Classes Im, Is, IIa, IIb plus epidural sets
– *MD 0104 – Non-active medical devices with measuring function Limited to devices of Classes Im, Is, IIa, IIb
– *MD 0105 – Non-active ophthalmologic devices Limited to devices of Classes Im, Is, IIa, IIb
– *MD 0106 – Non-active instruments Limited to devices of Classes Im, Is, IIa, IIb
– *MD 0108 – Non-active medical devices for disinfecting, cleaning, rinsing Limited to devices of Classes Im, Is, IIa, IIb
*MD 0200 – Non-active implants
– *MD 0201 – Non-active cardiovascular implants Limited to cardiovascular stents including stent inserting tools plus cardiac valves not containing animal tissues
– *MD 0202 – Non-active orthopaedic implants Limited to devices of the Class IIb
– *MD 0203 – Non-active functional implants Limited to devices of the Class IIb oesophageal, ureteral and biliary stents
– *MD 0204 – Non-active soft tissue implants Limited to devices of the Class IIb plus injection implants based on hyaluronic acid and hyaluronic acid derivates
*MD 0300 – Devices for wound care
– *MD 0301 – Bandages and wound dressings Limited to devices of Classes Is, IIa, IIb plus wound dressing being wholly or mainly absorbed and/or incorporating medicinal substances
– *MD 0302 – Suture material and clamps Limited to devices of Classes Is, IIa, IIb plus devices being wholly or mainly absorbed plus sutures for the central circulatory system
– *MD 0303 – Other medical devices for wound care Limited to devices of Classes Is, IIa, IIb plus wound care devices being wholly or mainly absorbed and/or incorporating medicinal substances
*MD 0400 – Non-active dental devices and accessories
– *MD 0401 – Non-active dental equipment and instruments Limited to devices of Classes Im, Is, IIa, IIb
– *MD 0402 – Dental materials Limited to devices of Classes Is, IIa, IIb
– *MD 0403 – Dental implants Limited to devices of Classes IIa, IIb
*MD 1100 – General active medical devices
– *MD 1101 – Devices for extra-corporal circulation, infusion and haemopheresis Limited to devices of Classes Im, Is, IIa, IIb
– *MD 1102 – Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia Limited to devices of Classes Im, Is, IIa, IIb
– *MD 1103 – Devices for stimulation or inhibition Limited to devices of Classes Im, Is, IIa, IIb
– *MD 1104 – Active surgical devices Limited to devices of Classes Im, Is, IIa, IIb
– *MD 1105 – Active ophthalmologic devices Limited to devices of Classes Im, Is, IIa, IIb
– *MD 1106 – Active dental devices Limited to devices of Classes Im, Is, IIa, IIb
– *MD 1107 – Active devices for disinfection and sterilisation Limited to devices of Classes Im, Is, IIa, IIb
– *MD 1108 – Active rehabilitation devices and active prostheses Limited to devices of Classes Im, Is, IIa, IIb
– *MD 1111 – Software Limited to devices of Classes Im, IIa, IIb
*MD 1200 – Devices for imaging
– *MD 1201 – Imaging devices utilising ionizing radiation Limited to devices of Classes Im, Is, IIa, IIb
– *MD 1202 – Imaging devices utilising non-ionizing radiation Limited to devices of Classes Im, Is, IIa, IIb
*MD 1300 – Monitoring devices
– *MD 1302 – Monitoring devices of vital physiological parameters Limited to devices of Classes Im, Is, IIa, IIb
*MD 1400 – Devices for radiation therapy and thermo therapy
– *MD 1402 – Devices utilising non-ionizing radiation Limited to devices of Classes Im, Is, IIa, IIb
– *MD 1403 – Devices for hyperthermia / hypothermia Limited to devices of Classes Im, Is, IIa, IIb
Horizontal technical competence Limitations
*MDS 7001 – Medical devices incorporating medicinal substances, according to Directive 2001/83/EC
*MDS 7006 – Medical devices in sterile condition Limited to devices sterilised by one of the following: Aseptic filling, Ethylene oxide sterilisation, Radiation sterilisation, Moist heat sterilization
*MDS 7009 – Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed Limited to devices being wholly or mainly absorbed
*MDS 7010 – Medical devices incorporating software /utilising software /controlled by software Limited to devices of Classes Im, Is, IIa, IIb

Why QVC?

QVC as a Certification Body involved in Certification & assessment is

  • Impartial
  • Having trained personnel having knowledge of requirements of assessments
  • Having adequate facilities or access to facilities like testing, documentation of regulation/standards needed to perform technical & administrative tasks
  • Maintaining confidentiality of the information gained during the assessment of a particular task
  • Involved in coordination activities organized by competent organizations

Your Benefits At A Glance

With our comprehensive solutions for explosion protection you can:

  • Ensure product safety and compliance worldwide.
  • Reach full compliance and certification prior to product placement.
  • Gain competitive advantage and greater market access with certification marks from an international Notified Body.
  • Tools used for Easy Access of database, reducing waiting time for documents to be transferred between agencies through conventional methods.
  • Reduce risk of company liability with documented safety standards.
  • Benefit from our exclusive one-stop-shop service, covering a wide range of international certification from a single source.