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Mar 30th, 2011

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Types of Drug/Device Combination Products in the EU

Definition and Example EU Class Regulatory Approval Route Notified Body? Notes
Type I Device intended to administer a drug;  e.g. a syringe marketed alone intended to be used to administer a drug Device Declaration of conformity by the manufacturer and attachment of CE symbol to the product prior to marketing Only required if the device has a measuring component or is sterile Conformity assessment route should reflect risk classification
Type II Device intended to administer a medicinal product, and the device and drug form a single integral product that is not reusable;  e.g. a prefilled syringe containing a drug or biologic Drug Drug must receive premarket approval according to 2001/83/EC.  Device component must meet relevant essential requirements of the MDD, which will be assessed by the authority submitted to (national drug authority or EMA) Not required, but is recommended for assessment of essential requirements of MDD Involving Notified Body and submitting its assessment of the device meeting the essential requirements of MDD will speed time to market
Type III Device with a drug as an integral component where the action of the drug is ancillary to that of the device;  e.g. a drug-coated stent Device Same as Type II, except that the Notified Body will provide a report to the competent authority regarding the usefulness of the combination product vs. the drug alone, and the competent authority will perform a review of CTD Module III Assessment of entire product is required Class III medical device, highest risk category, that must be CE marked prior to marketing
Type IV Device with a substance derived from human blood plasma as an integral component where the action of the drug is ancillary to that of the device;  e.g. Floseal Device Same as Type III Same as Type III Same as  Type III
Type V Device with an advanced therapy medicinal product (ATMP) as an integral part of the product.  Its cellular or tissue part must contain viable cells or tissues. Drug Entire product must be approved by EMA with involvement of its Committee for Advanced Therapies (CAT).  Device part must meet MDD.  May not be submitted through a national competent authority Recommended to assess the device part and submit a report to the sponsor for inclusion in filing application Use of a Notified Body for the device assessment and submitting that assessment to EMA will speed time to market

Types of Drug/Device Combination Products in the EU

Definition and Example

EU Class

Regulatory Approval Route

Notified Body?

Notes

Type I

Device intended to administer a drug; e.g. a syringe marketed alone intended to be used to administer a drug

Device

Declaration of conformity by the manufacturer and attachment of CE symbol to the product prior to marketing

Only required if the device has a measuring component or is sterile

Conformity assessment route should reflect risk classification

Type II

Device intended to administer a medicinal product, and the device and drug form a single integral product that is not reusable; e.g. a prefilled syringe containing a drug or biologic

Drug

Drug must receive premarket approval according to 2001/83/EC. Device component must meet relevant essential requirements of the MDD, which will be assessed by the authority submitted to (national drug authority or EMA)

Not required, but is recommended for assessment of essential requirements of MDD

Involving Notified Body and submitting its assessment of the device meeting the essential requirements of MDD will speed time to market

Type III

Device with a drug as an integral component where the action of the drug is ancillary to that of the device; e.g. a drug-coated stent

Device

Same as Type II, except that the Notified Body will provide a report to the competent authority regarding the usefulness of the combination product vs. the drug alone, and the competent authority will perform a review of CTD Module III

Assessment of entire product is required

Class III medical device, highest risk category, that must be CE marked prior to marketing

Type IV

Device with a substance derived from human blood plasma as an integral component where the action of the drug is ancillary to that of the device; e.g. Floseal

Device

Same as Type III

Same as Type III

Same as Type III

Type V

Device with an advanced therapy medicinal product (ATMP) as an integral part of the product. Its cellular or tissue part must contain viable cells or tissues.

Drug

Entire product must be approved by EMA with involvement of its Committee for Advanced Therapies (CAT). Device part must meet MDD. May not be submitted through a national competent authority

Recommended to assess the device part and submit a report to the sponsor for inclusion in filing application

Use of a Notified Body for the device assessment and submitting that assessment to EMA will speed time to market

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