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 

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   

Combination Products – Design And Development Consultant

Combination product as indicated by the Central of Federal Regulation CFR is expressed as a product that includes a medical device /or a medication/or a biologic consolidating any two of these classifications and at some point even every one of the three. The well-known term of combination product is the drug eluting stent (DES) which is a scaffold covered with a drug to prevent scar tissue from developing in the supply artery. 

Combination Products Project Development Process & Design Control

The Pharmaceutical organization which manufacturers the combination products are expected to implement the 21 CFR Part 210 and 211 and 21 CFR Part 820 for their manufacturing sites of the combination products. At the end of the design Phases, the DHF is compiled and shall be presented during the audits. The DMR shall be extracted from the DHF for the routine use and the tech transfer. The requirements mentioned in the DMR shall be used to create the DHR to demonstrate the routine production and compliances. As per the requirements of the ISO 13485:2016, the medical device file shall be established. 

Operon Strategist assists companies and medical device manufacturers by providing consultancy services that support the registration of drug-device Combination Products. We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug  (21 CFR 210/211), Device (21 CFR 820) and 21 CFR Combination Products (21 CFR Part 4).

Read More  - Combination Products – Design And Development Consultant

Visit Us - Medical device consulting

Read More Article - 

1.Orthopedic Implants Manufacturing

2.Dental Implants Manufacturing

3.Blood Collection Tubes Manufacturing

4. How to start the Manufacturing of Disposable Syringes?

5. disposable syringe manufacturers

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