Consultation on draft guideline on quality requirements for medical devices in combination products

June 6, 2019 Gubba Pharma In E News

EMA has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation.
The guideline addresses the new obligations in Regulation (EU) 2017/745 on medical devices, in particular the requirements under Article 117. This article foresees that the marketing authorisation application should include a CE (Conformité Européenne) certificate or declaration of conformity for the device or, in certain cases, an opinion from a notified body (NB) on the conformity of the device.
The guideline covers devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product information of the medicine but obtained separately. It specifies which information about the device needs to be submitted as part of the initial marketing authorisation application and subsequently during the product lifecycle. It also contains a proposed template for the NB opinion on the conformity of the device to the relevant general safety and performance requirements laid down in Regulation (EU) 2017/745.
It is intended that this guideline will increase transparency and consistency of information in regulatory submissions, reducing work for all stakeholders and ultimately improving patient safety.
Stakeholders are invited to send their comments by 31 August 2019 to QWP@ema.europa.eu using the template provided.
EMA will take into account comments received during the consultation, with a view to finalising the guidelinebefore the regulation fully applies on 26 May 2020.


Source : ema.europa.eu/en

About the author

Gubba Group:


Plot no-118-A, Five Star Industrial Area, MIDC, Shendra, Aurangabad.


+91 – 8008212626


support@gubbagroup.com


Survey No.271,Muppireddypalli (Village),Toopran Mandal, Medak District, Hyderabad,Telangana


+91 – 8008212626


support@gubbagroup.com


Survey No.255, Kandlakoya Village, Medchal R R Dist, Hyderabad,Telangana


+91 – 8008212626


support@gubbagroup.com


Plot No.109 to 111&115 IDA Medchal R R District, Hyderabad,Telangana


+91 – 8008212626


support@gubbagroup.com


Plot No. 101 & 103 IDA Medchal R R District, Hyderabad,Telangana


+91 – 8008212626


support@gubbagroup.com


Plot No. 101 & 103 IDA Medchal R R District, Hyderabad,Telangana


+91 – 8008212626


support@gubbagroup.com


Plot No. 101 & 103 IDA Medchal R R District, Hyderabad,Telangana

+91 – 8008212626

support@gubbagroup.com


Survey No. 46, Mediciti Hospital, Rajbollaram (village),Medchal R R Dist, Hyderabad,Telangana

+91 – 8008212626

support@gubbagroup.com


Survey No.741 Lalgadi Malakpet VillageShameerpet Mandal, R R Dist, Hyderabad,Telangana

+91 – 8008212626

support@gubbagroup.com


Plot : C-8/2a, Industrial Area, Uppal, Hyderabad,Telangana

+91 – 8008212626

support@gubbagroup.com


Plot No.1, Survey No.85/A, Yellampet, Medchal R R Dist, Hyderabad,Telangana

+91 – 8008212626

support@gubbagroup.com


Plot No.2 Survey No.85/A, Yellampet, Medchal R R Dist, Hyderabad,Telangana

+91 – 8008212626

support@gubbagroup.com


Plot No.2 Survey No.85/A, Yellampet, Medchal R R Dist, Hyderabad,Telangana

+91 – 8008212626

support@gubbagroup.com


Survey No.150&151, Athavelli village, Medchal R R Dist, Hyderabad,Telangana

+91 – 8008212626

support@gubbagroup.com


Survey No.150&151, Athavelli village, Medchal R R Dist, Hyderabad,Telangana

+91 – 8008212626

support@gubbagroup.com


Survey No : 84 C & G, Yellampet Village, Medchal Mandal, R.R Dist, Hyderabad,Telangana

+91 – 8008212626

support@gubbagroup.com


MCJR+C4 Nutankal, Telangana


080082 99626


support@gubbagroup.com


Banda Mailaram, Telangana 502336


095153 75626


support@gubbagroup.com


Plot : C-8/2a, Industrial Area, Uppal, Hyderabad,Telangana


8008212626


support@gubbagroup.com