Combination Products - Case Studies

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Drug and Auto-injector Registration in the EU Market

QUICK FACTS

CLIENT
International Drug & Device Manufacturer

SERVICES SUPPLIED 

• Regulatory Pathway to Combination Product registration in the EU
• Recommendation of Notified Body - EU, CE Marking
• Audit on Device Essential Requirements
• Audit on ISO - 13485:2016 Standard Requirements (Device GMP)

​WHERE​

• ​European Union

OBJECTIVE

Registration of a drug (cartridge) and auto-injector (pen) delivery system primarily in the EU market.  The drug was previously licensed in the EU through the EMA (European Medicines Agency)

SOLUTION DETAILS

In a combination product, such as this, what needs to be proven is that the device delivery system brings no deleterious effects to the drug.  In the EU market, hiring a Notified Body, who had expertise in assessing auto-injectors, to CE Mark the product for the European market was the first stop.  Assessing the company's data on compliance against the EU Device Essential Requirements checklist was the next step in the regulatory process.  Organizing extractable/leachable testing for the drug cartridges was also needed and became the next step in the project.  Then conducting mock audits of the manufacturing facilities involved in producing the multi-component auto-injector, against ISO-13485:2016 (global device GMP) standards, were then conducted.  This became the Conformity Assessment pathway chosen between the client and Notified Body.

OUTCOME

In the following the strategy and step-wise project layout, the client:

• Received a CE Mark on the device components of the combination system
• Received a combination product license with EMA (European Medicines Agency)
• Received an ISO-13485:2016 Certificate for the manufacturing facility.
  

​Because of project planning and timely execution, the whole project was completed in approximately 12 months. 
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Drug/Pump/Enteral Tubing - U.S. & EU Markets

Quick FActs

CLIENT
International Medical Device Manufacturer

SERVICE SUPPLIED

• Regulatory Pathway to Combination Product Registration
• 510K Submission - US
  
• Recommendation of Notified Body - EU, CE Marking
  
• Audit on Device Essential Requirements
  
• Audit on ISO 13485:2016
  

WHERE​

• United States
• European Union

OBJECTIVE

Registration of a drug, peristaltic pump and drug delivery tube, primarily for orphan indications in the U.S and EU.  The drug was previously licensed in both the U.S. and EU markets

SOLUTION DETAILS

Ina combination product, such as this, what needs to be proven is that the device system components bring no deleterious effects to the drug.  In the U.S. market is involved a 510 k submission to the FDA, highlighting a device predicate from the U.S. market.  For the EU, securing a Notified Body to CE Mark the product from the European market was the immediate need.  Assessing the company's data on compliance against the EU Device Essential Requirements checklist was the next step in the process.  Then conducting mock audits of the manufacturing facility against ISO 13485:2016 (global device GMP) standards was key to preparing for a smooth audit and quick conformity fo a compliant device and CE Marking.

OUTCOME

In the following the strategy and step-wise project layout, the client:

• Received their 510K approval on the device
• Received a U.S. registration for a combination product
• Received a CE Mark on the device components of the combination system
• Received a combination product license with EMA (European Medicines Agency)
• Received an ISO-13485:2016 Certificate for the manufacturing facility

 Because of project planning and timely execution, the whole project was completed in slightly under 12 months.

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