Quality & Regulatory Requirements for Drug Device Combination Products in the EU

Days
Hours
Minutes
Seconds

Quality & Regulatory Requirements for Drug Device Combination Products in the EU

online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

As delivery system technology and medical devices continue to develop, the combination of drug-device and device-drug modalities are rapidly increasing and the distinction between the modalities is becoming blurred. In some situations, it is difficult to determine as to which regulations, submission procedure and pathway to market must be followed. Correct classification is a key as in the European Union, combination products are regulated as either medicinal products or medical devices.

This course will cover the definition of combination products, EU regulatory pathways, and will explain the current state of developments as medical device manufacturers and marketing authorisation holders prepare for the new requirements.

meet the training leader
Dr. Tina Amini
Director
TA Medtech & Combinaiton products Consulting Ltd, UK
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Quality and Regulatory Requirements for Drug Devices Combination Products online live training organized by Fleming_Agenda Cover
Quality and Regulatory Requirements for Drug Devices Combination Products online live training organized by Fleming_Agenda Cover
Quality and Regulatory Requirements for Drug Devices Combination Products online live training organized by Fleming_Agenda Cover
key training

Topics

Regulatory & legislative requirements for Drug Device Combination Products

Borderline classification in EU: Medical Device or Medicinal product?

EU market access for medicines with a device component

Key considerations for Combinations regulated as a medicinal product

EU market access for devices with an ancillary medicinal substance

EU MDR key changes and its impact on Drug Device Combination Products

Case study on combination products regulated as medical devices

Labelling requirements for drug device combination products

Life cycle management

Post-market surveillance for combination products

Key takeaways

Medtech and Pharmaceutical/biotech companies increasingly must stay informed about implications of the EU MDR. EU MDR came into full effect on 26 May 2021 and encompasses all integral, single-use combination products regulated as medicinal products. In the European Union, combination products are regulated as either medicinal products or medical devices.

For marketed CE Marked devices under MDD and AIMDD whether standalone or co-packaged with medicinal products, these devices must also conform to MDR.

“Substantial” device design changes of already marketed single integral combination products will require NB opinion. To ensure that operations conform with the EU MDR, pharmaceutical/biotech companies must have compliant design controls, integrated risk-management procedures, and improved processes for complaint handling. Companies must have closer oversight of their device and component manufacturers. Because compliance is an ongoing activity that lasts throughout a device’s product lifecycle, businesses are encouraged to incorporate device compliance processes into their operations as soon as possible. Given overdemand for notified bodies in the regulatory arena, an early start can make the difference between a product market freeze and full compliance for market access.

Testimonials

Registration

Training ticket

Online Live Stream
FROM
1496

Contact us

Related events

DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

Name
Job
Company
Bio
Name
Description