IMPLICATIONS FOR DRUG-DEVICE COMBINATION PRODUCTS

 

The drug -device combination (DDC) products are the therapeutic or diagnostic products that combine drugs, devices or biological products which leads to safe and effective treatments. It helps in targeted drug delivery, localized drug administration and individualized medicine therapy. With the advancement in technology drug-device combination products have developed a unique form of medicinal products that has cardiovascular, neurological, orthopaedic applications. The widely used DDC combination products are autoinjectors, inhalers, antibiotic-loaded bone cements, bioartificial liver devices, pre-filled nebuliser, pre-filled pen, pre-filled syringe, transdermal patch etc. 

EUROPE’S MDR AND CE MARKING  

The European Medicines Agency (EMA), has put forth the guidance for compliance issues for manufacturers of combination products with drug and medical device components. For drug-device combination products to be marketed in the European market it should undergo conformity assessment results or CE mark issued by notified bodies. For the devices that do not have CE marking the manufacturers need to submit conformity regarding components to MDR requirements from the notified bodies. 

Read Article 

• EU MDR checklist – Effects on Medical Devices
• Regulating medical device combination products

IMPLICATION OF MDR ARTICLE 117 FOR DRUG-DEVICE COMBINATION PRODUCTS

The medicinal product and the medical device are combined to form an integral product and are subjected to EU Medical Device Regulation (MDR) 2017/745. The European Commission under the medical device regulation (MDR) has introduced article 117 which states the requirements for manufacturers for placing drug-device combination products into the market. 

Read More - Drug -device combination (DDC) products 

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2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device   

EUROPEAN IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION

 

IN VITRO DIAGNOSTIC MEDICAL DEVICE REGULATION

Medical devices have a vital role in providing better diagnosis, prevention, Screening, monitoring, and treatment of various diseases. The COVID -19 pandemic challenge has shown the necessity to have accurate diagnostics and a stringent framework for the in vitro medical devices (IVDs). IVDs are biological tests that can detect disease, condition and infections. In vitro means glass that means the tests are usually conducted in glass test tubes. The examples of IVDs include Pregnancy test device, Glucometer kits to monitor blood sugar, HIV test kit, COVID 19, and many more. 

EUROPEAN IN VITRO DIAGNOSTIC MEDICAL DEVICE REGULATION (EU IVDR): AN OVERVIEW  

 The EU lawmakers did not change any requirements of the In vitro Diagnostic Regulation (IVDR) but only changed the transitional provisions to allow the Regulation’s gradual application.EU updated the rules with a purpose to improve the safety of IVDs. The duration of transition periods depends on the type of device. For example, the transition period for higher risk devices that is class D such as HIV or Hepatitis and few Class C devices such as influenza is until May 2025 and 2026, while lower risk devices belonging to Class A and B   have transition periods till May 2027. 

Read More – IVDR Technical Documentation

CLASSIFICATION OF DIAGNOSTIC DEVICES UNDER IVDRs. 

According to IVD Regulation (EU) 2017/746, medical devices are classified as classes A, B, C and D, based on the intended purpose of the devices and risks associated. 

Read More – IVDR Classification – CE marking

The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) has laid down a new regulatory framework for in vitro diagnostic medical devices.  The examples include HIV tests, pregnancy tests or SARS-CoV-2 tests. There is an increase in the involvement of independent notified bodies. Manufacturers will have to adapt quality management systems for their devices so as to apply to a notified body well in advance before the transition periods.  

Read More - IN VITRO DIAGNOSTIC MEDICAL DEVICE REGULATION

Read More Article - 

1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device