+91 9607006692 / 6823 / 6973 / 6945 / 4749

Product Certifications:

SIGNIFICANT CHANGES AHEAD FOR MEDICAL DEVICE/ IN VITRO DIAGNOSTICS DEVICE MANUFACTURERS

The Medical Device Regulation (MDR) has entered into force on May 26th 2017. The MDR will replace the current EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

Manufacturers of currently approved medical devices will have a transition time of three years until May 26th 2021 (date of application) to meet the requirements of the MDR. The new MDR provides an additional time after the date of application allowing to place new products under the MDD for max. 4 more years on the market. Additional requirements and limitations will apply for this extended transition period.

The new European In Vitro Diagnostic Regulation was published in the Official Journal of the European Union on 5th May 2017. The Regulations will enter into force on May 25th 2017, marking the start of the transition period for manufacturers selling IVD devices into Europe. The IVDR, which replaces IVD Directive (98/79/EC), has a transition period of five years, after which the Regulation will apply, and no new applications against the Directives will be accepted. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new, more stringent requirements

From May 2017 to May 2022, IVDs will start to transition from being CE marked under the current IVD Directive 98/79/EC to being CE marked under the new IVD Regulation (EU) 2017/746.

However, the transition may last until at least May 2024 for those IVDs that are certified by a Notified Body under the current Directive. No new certifications under the current Directive can take place after 26 May 2022.

EU Member State authorities and Notified Bodies will continue to oversee the EU market, ensuring that all IVDs are fit for purpose and reliably provide information to be used for diagnostic purposes, regardless of whether they are CE marked under the current Directive or the Regulation.

An IVD is not inferior simply because it is CE marked under the current Directive instead of under the new Regulation.

Regulatory documentation – such as Declarations of Conformity, certificates, labels and instructions for use – issued under the current Directive, may remain valid until up to approximately May 2024, and can both continue to be used and will lawfully remain in circulation.

  • MDR 2017/745 – Medical Device Regulation enforced w.e.f. May 26th 2017.
  • IVDR 2017/746 – In Vitro Diagnostic Devices Regulation enforced w.e.f. May 25th 2017
  • MDD 93/42/EEC – Medical Device Directive valid till May 26th 2021
  • IVDD 98/79/EC – In Vitro Diagnostic Devices Directive valid till May 26th 2022

The CE mark audit and certification services are provided in co-operation with EU based and recognised Notified Bodies.

We have competent and adequate human resources in terms of Lead Auditors, Auditors and Technical Experts with commitment to provide effective and efficient audit and certification services, ranging from Quality Management Systems Certifications to Product Certifications confirming to various Standards, Practices and Code of Conduct.

Our audits empower organisations to monitor and update their business processes. This leads organizations to compete and grow at national and international levels.

Training

  • Awareness training/Internal Auditor Training/Lead Auditor Training on ISO 9001, ISO 13485.
  • Awareness Training on MDD 93/42 EC, IVD 98/79 EC, MDR 2017/745 , IVDR 2017/746

Disclaimer: All the training programs are conducted at neutral venues. The training materials provided and taught during the training program are available in public domain. Customised training programs which may be misinterpreted as Consultancy are not provided.

Management System Certifications

Zenith provides audit and certification services as per ISO 13485 Medical Devices – Quality Management Systems and ISO 9001 Quality Management Systems to organizations who are covered in the below mentioned Technical Areas of Medical Devices and In-Vitro Diagnostic.

Medical Devices Technical Area (IAF MD9) for ISO 13485 (Codes & Description of Technical Area)

A.1.1 – Non-active medical devices

General non-active, non-implantable medical devices

  • Non-active devices for anaesthesia, emergency and intensive care
  • Non-active devices for injection, infusion, transfusion and dialysis
  • Non-active orthopaedic and rehabilitation devices
  • Non-active medical devices with measuring function
  • Non-active ophthalmologic devices
  • Non-active instruments
  • Contraceptive medical devices
  • Non-active medical devices for disinfecting, cleaning, rinsing
  • Non-active devices for in vitro fertilization (IVF) and assisted reproductive technologies (ART)
  • Non-active medical devices for ingestion

Non-active implants

  • Non-active cardiovascular implants
  • Non-active orthopaedic implants
  • Non-active functional implants
  • Non-active soft tissue implants

Devices for wound care

  • Bandages and wound dressings
  • Suture material and clamps
  • Other medical devices for wound care

Non-active dental devices and accessories

  • Non-active dental devices/equipment and instruments
  • Dental materials
  • Dental implants

Non-active medical devices other than specified above

 A.1.2 – Active medical device (Non-implantable)

General active medical devices (non-implantable)

  • Devices for extra-corporal circulation, infusion and haemopheresis
  • Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
  • Devices for stimulation or inhibition
  • Active surgical devices
  • Active ophthalmologic devices
  • Active dental devices
  • Active devices for disinfection and sterilization
  • Active rehabilitation devices and active prostheses
  • Active devices for patient positioning and transport
  • Active devices for in vitro fertilization (IVF) and assisted reproductive technologies (ART)
  • Software
  • Medical gas supply systems and parts thereof

Devices for imaging

  • Devices utilizing ionizing radiation
  • Devices utilizing non-ionizing radiation

Devices for monitoring

  • Monitoring devices of non-vital physiological parameters
  • Monitoring devices of vital physiological parameters

Devices for radiation therapy and thermo therapy

  • Devices utilizing ionizing radiation
  • Devices utilizing non-ionizing radiation
  • Devices for hyperthermia / hypothermia
  • Devices for (extracorporal) shock-wave therapy (lithotripsy)

Active (non-implantable) medical devices other than specified above

 A.1.4 – In Vitro Diagnostic medical device (IVD)

Reagents and reagent products, calibrators and control materials for:

  • Clinical Chemistry
  • Immunochemistry (Immunology)
  • Haematology/Haemostasis/ Immunohematology
  • Microbiology
  • Infectious Immunology
  • Histology/Cytology
  • Genetic Testing

In Vitro Diagnostic Instruments and software

IVD medical devices other than specified above

 A.1.5 – Sterilization methods for medical devices

  • Ethylene oxide gas sterilization (EOG)
  • Moist heat
  • Aseptic Techniques
  • Radiation sterilization (e.g. gamma, x-ray, electron beam)
  • Sterilization method other than specified above

 A.1.6 – Devices Incorporating/Utilizing Specific Substances/Technologies

  • Medical devices incorporating medicinal substances
  • Medical Devices Utilizing Tissues of Animal origin
  • Medical devices incorporating derivate of human blood
  • Medical devices utilizing micromechanics
  • Medical devices utilizing nanomaterials
  • Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed
  • Medical devices incorporating or utilizing specific substances/technologies/elements, other than specified above.

 A.1.7 – Parts and Services 

  • Raw materials
  • Components
  • Subassemblies
  • Calibration services
  • Distribution services
  • Maintenance services
  • Transportation services
  • Other services

 Zenith provides these audit and certification services under accreditation regime of Internationally recognised Accreditation Bodies.

Contact us to learn more about how we can serve you?

Contact us

Siddhesh Optimus, B Wing, 01A, S.No. 211, Viman Nagar, Pune – 411014, MH, India

+91 9607006692 / 6823 / 6973 / 6945 / 4749

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Zenith Quality Assessors Pvt. Ltd. operates quality management system certification schemes, product certification schemes and testing activities under internally designated business divisions

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