It could still mean a recommendation for adoption subject to the outstanding issues being answered...as long as Significant Objections don't remain
Committee for Medical Products for Human Use (CHMP)
CHMP day 180 list of outstanding issues - DRAFT
Consultation on an ancillary medicinal substance incorporated in a medical device
Medical device:
Ancillary medicinal substance:
EMEA/H/D/
Applicant:
INN (or common name) of the ancillary medicinal substance:
2
Applicant for medical device CE certification:
3
Notified body:
4
Applied intended purpose of the device:
5
Intended purpose of the ancillary medicinal substance in the device:
6
Pharmaceutical form(s) and strength(s) of the ancillary medicinal substance:
7
Rapporteur’s contact person:
EMA product team leader:
Tel: Fax: E-mail:
Tel: Fax: E-mail:
8
Names of the Rapporteur’s assessors: (Internal and external)
Tel: Fax: E-mail:
LIST OF ABBREVIATIONS
1. Recommendation
Based on the review of the submitted data and the Applicant’s response to the CHMP LoQ, the CHMP considers that the claim for quality and safety including the clinical benefit/risk profile of as a component of the medical device . <7>.> <6> <7>.> 2. Executive summary 2.1. Problem statement 2.2. About the product 2.3. Type of application and other comments on submitted dossier 3. Scientific overview and discussion 3.1. General information 3.2. Quality documentation 3.2.1. Inspection status
[Note: Include comments on the documentation provided regarding GMP compliance and manufacturing licenses of the manufacturing sites of the ancillary medicinal substances. Please note that this procedure does not trigger any inspection of the manufacturing sites] 3.2.2. For the ancillary medicinal substance or the ancillary human blood derivative itself Drug substance Drug product [Include relevant headings concerning the documentation provided in line with the format of Volume 2B, CTD of NTA (Module 2.3 and Module 3)] 3.2.3. For the ancillary medicinal substance or the ancillary human blood derivative as incorporated in the medical device [Include relevant heading from MEDDEV 2.1/3 rev. 3, Section C.3, 2) b)] 3.2.4. Discussion and conclusion on 3.3. Non-clinical documentation [Include relevant heading from MEDDEV 2.1/3 rev. 3, Section C.3, 3)] 3.3.1. Discussion and conclusion on the non-clinical documentation 3.4. Clinical evaluation 3.4.1. Usefulness of the ancillary medicinal substance incorporated in the medical device as verified by notified body [Note: The usefulness of the ancillary medicinal substance in the medical device should be addressed by clinical evaluation or by cross-reference to other sections of the dossier, as applicable.] 3.4.2. Clinical safety of the ancillary medicinal substance incorporated in the medical device [Note: The clinical safety data provided by the notified body to the competent authority will address the safety of the medical device in its entirety] 3.4.3. Clinical benefit/risk profile of the ancillary medicinal substance incorporated in the medical device 3.4.4. Discussion and conclusion on the clinical evaluation 4. Overall conclusions [Note: This section refers to the overall conclusions on the quality and safety, including the clinical benefit/risk profile of the ancillary medicinal substance in the context of its use in the medical device]
5. List of outstanding issues to be addressed in writing 5.1. Quality aspects 5.1.1. For the ancillary medicinal substance or the ancillary human blood derivative itself Major objections Other concerns [Questions concerning the documentation provided in line with the format of Volume 2B, CTD of NTA (Module 2.3 and Module 3)] 5.1.2. For the ancillary medicinal substance or the ancillary human blood derivative as incorporated in the medical device Major objections Other concerns [Include relevant heading from MEDDEV 2.1/3 rev. 3, Section C.3, 2)] 5.2. Non-clinical aspects Major objections Other concerns [Include relevant heading from MEDDEV 2.1/3 rev. 3, Section C.3, 3)] 5.3. Clinical aspects Major objections Other concerns [Include questions regarding – clinical safety and clinical benefit/risk profile] 6. [Remarks to the Notified body include any relevant issues or action to be considered by the Notified body when providing a CE mark] 7.
The CHMP would recommend that the notified body request the following from the medical device manufacturer for device approval:
Area1
Description
1
2
1 Areas: quality, safety including clinical benefit/risk profile. Recommended measures to the Notified body include any data that the Notified body may consider requesting to the medical device manufacturer (e.g. submission of a final stability report or notification of out-of-specification results during stability studies). This data will not be reviewed by the European Medicines Agency]
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