EMWA goes virtual!
Come and join us for EMWA’s first virtual Expert Seminar Series (ESS) on medical devices
Date: Tuesday, 9 June 2020, from 9:30 to 12:00 CEST
The MDR application date may have been postponed by one year but the requirements are as stringent as ever. This virtual ESS addresses topics that are highly relevant for MDR-readiness.
Please email head office with any questions or accessibility concerns.
Drug/ device combination regulation including Article 117
By Jonathan Sutch, BSI UK
Various products can fall under the term ‘drug/ device combinations’ yet the regulatory pathways may be different. With the introduction of the Medical Device Regulation (MDR) there are new requirements for these types of devices. In particular, drug/ device combinations such as some inhalers or pre-filled syringes will fall under Article 117. This requires the device part of the combination to be assessed by a Notified Body and the Notified Body Opinion Report to be included in the Market Authorisation Application; a big change from the current process.
This talk will describe various drug/ device combinations, such as devices co-packaged with medicines, devices containing an ancillary medicinal substance and integral drug/ device combinations. We will cover the different regulatory routes, including Article 117, and highlight key changes required as a result of the implementation of the MDR.
The new EUDAMED under the MDR
By Richard Houlihan, Eudamed.eu
This presentation will cover the planned release of the new European medical device database (Eudamed) under the MDR. Any relevant Medical Device Coordination Group (MDCG) decisions relating to Eudamed will be referenced, for example decisions on legacy devices and nomenclature.
The presentation will cover
- the scope of MDR Eudamed, the modules it includes, and which ones will be used directly by manufacturers.
- the steps manufacturers can and should take to prepare for MDR Eudamed, including skills gap analysis suggestions.
- the benefits of MDR Eudamed to both the patient and the manufacturers.
Q&A with our panel of experts
Jonathan Sutch, Richard Houlihan
Jane Edwards (BSI)
Gillian Pritchard (Sylexis)
Moderator: Raquel Billiones
EMWA is offering a special price for this first virtual ESS €50 for EMWA member and €75 for non-members.
|Click here to register|
About our speakers:
Jonathan Sutch trained as a Pharmacist at the London School of Pharmacy and worked as a hospital pharmacist prior to completing a PhD in Pharmaceutical Sciences at Nottingham University. He worked at AstraZeneca working with oral drug products including leading a complex Quality by Design submission and then Patheon, a Pharmaceutical Contract Research and Development Organisation working on hundreds of clinical candidates. Since 2017 Jon has worked in the medical device industry with BSI, a Notified Body. At BSI he works as a medicinal technical specialist working with device/ drug combinations.
Richard Houlihan is an international speaker on MDR Eudamed. During his time with the European Commission (EC), he was responsible for Eudamed 2 (from 2011) and was the technical manager for the MDR Eudamed from July 2017 until April 2019 when he left the EC to return to the private sector. During his technical manager role, he was responsible for the design, development, and implementation of the MDR Eudamed application and the associated data exchange for machine-to-machine XML uploads.
Richard has been in IT related businesses for 25+ years. He holds a BSc in Computing and a MBA Information management.