Resources for professionals in medical devices and combination products

TOPRA is committed to assisting the regulatory profession in accessing the most relevant and up-to-date news and resources in the medical devices and combination products space.

Here are some of the ways we can help you in 2020 and beyond.

Special event

TOPRA Drug-Device Combination Products Stakeholder Workshop

This one-day event will focus on the practical implementation of MDR Article 117 and EMA guidance on ‘drug-device combination products’.

When: 3 December 2019 
Where: DoubleTree By Hilton Amsterdam Centraal Station, the Netherlands 

 

Basics of Medical Device Regulatory Affairs

Our Basics courses on medical devices in the EU occur twice a year. This one-day course will give you a comprehensive overview of regulatory requirements and considerations for medical devices.

Our next course is:

• Essentials of In Vitro Diagnostic Regulatory Affairs - 29 April 2020
• Essentials of European Medical Device Regulatory Affairs - 23 June 2020

 

Medical Device Introductory Course

TOPRA delivers an annual three-day Introductory course for anyone new to Medical Device Regulatory Affairs looking to gain an in-depth understanding of the requirements for medical devices in the EU. 

• The Medical Device Introductory Course - 8–10 July 2020

 

TOPRA Masterclasses

We offer medical devices Masterclasses throughout the year aimed at experienced regulatory professionals. Some of our upcoming Masterclasses include:

• Regulation of In Vitro Diagnostic Medical Devices - 12 February 2020
• Design Development and Certification of Medical Devices - 4 March 2020
• Clinical Evaluation of Medical Devices - 3 June 2020
• Post-Market Surveillance and Vigilance for Medical Devices - 2 September 2020

See our Masterclasses schedule for other courses focused on medical devices.

 

Webinars

TOPRA regularly hosts live webinars on topics related to medical devices. You can find a list of upcoming and archived webinars here .

MSc Regulatory Affairs – Medical Devices

TOPRA's MSc Regulatory Affairs - Medical Devices is a qualification designed not only to help you broaden your regulatory expertise whilst developing your career, it is also fully flexible - designed to suit you so you can start when you want and pay as you go.

 

Article: Medical Device Standards Update

The November 2019 issue of Regulatory Rapporteur features an article listing recent changes to EU and US medical device standards.

Here is a longer version of what appeared in print. 

TOPRA Annual Symposium 2020

TOPRA’s Annual Symposium will be held in Brussels, Belgium, from 5–7 October 2020, with two days exclusively covering medical devices and IVDs.

The conference's schedule of topics and roster of speakers will begin to be published in spring 2020.

TOPRA Special Interest Networks (SPINs)

We have a lively TOPRA SPIN in Medical Technologies community. If you are a member we recommend you join in today and take part in the conversation. Members can sign up to a SPIN in the My TOPRA area.

 

Devices newsletter and MedBoard discount

TOPRA members can receive a monthly email newsletter - MedDev Update - highlighting the latest key regulatory developments in the global medical devices sector. 

To subscribe to MedDev Update, log in to the site, go to the 'My Account' area and tick the box to receive the newsletter from the choices on the My Communications Preferences page.

MedDev Update is produced in collaboration with MedBoard, a single integrated medical device information platform that allows users to access the latest news, official regulatory information and regulatory developments in a fast, accessible and user-friendly way.

As a TOPRA member, you or your organisation can subscribe to MedBoard at a discounted rate.