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 2022 and beyond:

Software as a medical device

View our upcoming regulatory courses that explores the topic of software as a medical device. In addition, resources to assist with classification can be found here.

Find out more

Basics of Medical Device Regulatory Affairs

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

Upcoming courses: 

• Essentials of European Medical Device Regulatory Affairs   | 4 May 2022 | London, UK or online

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 | 5–7 July 2022 | London, UK

TOPRA Masterclasses

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

• Design, Development and Certification of Medical Devices | 23–25 March 2022 | London, UK & online
• Clinical Evaluation of Medical Devices | 23–25 May 2022 | London, UK & online  
• Post-Market Surveillance and Vigilance for Medical Devices| 5–7 September 2022 | London, UK & online 

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

Webinars

TOPRA regularly hosts live webinars on topics related to medical devices. See our list of upcoming and archived webinars to see what's currently available.

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.

Medical Device Standards Update

The latest changes to EU and US medical device standards can be downloaded here   (PDF). A summarised version is published in Regulatory Rapporteur twice a year.

TOPRA Special Interest Networks (SPINs)

We have a lively TOPRA SPIN in Medical Technologies community. Members are invited to log in to TOPRA's online Communities platform to be a part of the MedTech SPIN. We have also introduced two new sub groups focussing on ‘Combination products’ and ‘Software as a medical device’. Contact membership@topra.org if you wish to be involved in the regular virtual meetings linked to these areas of special interest.

Medical 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.