With innovation leading to the increasing integration of drugs and devices, traditional boundaries between medicines and medical devices are often blurred. As a result, determining the correct regulatory pathway for drug-device combination products (DDCs) can prove challenging.
The development of these products involves interaction between EU and national regulations, one of which, the Medical Devices Regulation (MDR), is set to become fully applicable on 26 May 2021.
In this briefing we examine the key changes to the regulatory pathway for DDCs.
Click here or on the image below to download this briefing, or click the following links to view the rest of our series:
- Our Medical Devices Publication
To assist medical device companies navigate the new MDR & IVDR regulatory regime we published under one roof the Regulations with easy access to the annexes and a table of equivalence comparing key articles from the Medical Devices Directives 93/42/EEC and 90/385/EEC and In Vitro Diagnostic Medical Devices Directive 98/79/EC with the MDR & IVDR. - Low Rate of Notified Body Designations under MDR and IVDR Causes Bottleneck Concerns for the European MedTech Industry
We explore which EU Notified Bodies have been designated under the new Medical Devices and In-Vitro Devices Regulations, and the slow pace of approval despite increased demand for their services. - Act Now to be Ready on Time – Guide to New Classification Rules for In Vitro Diagnostic Medical Devices
We outline the key changes to the classification of in vitro diagnostic medical devices in advance of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) becoming fully applicable on 26 May 2022. - Medical Devices – New Classification Rules – Is your Business Ready?
A guide to the classification of devices under the new Medical Devices Regulation.
Recommended Insights
Article and Insights
8
Aug 2023
The Irish M&A market experienced a dip of 2% in the number of qualifying deals dur...

Partner
Stephen Keogh
Article and Insights
6
Sep 2023
Welcome to the September 2023 edition of our Asset Management & Investment Funds U...

Partner
Patricia Taylor
Article and Insights
21
Dec 2022
The Central Bank of Ireland highlights the key prudential risks that will inform i...

Partner
Eoin Caulfield
Article and Insights
27
Jan 2023
William Fry is pleased to celebrate the Council of Europe's annual Data Protection...

Senior Associate
Rachel Hayes
Article and Insights
17
Feb 2023
On 16 February 2023, the Central Bank published a Dear CEO Letter addressing the C...

Partner
Shane Kelleher
Article and Insights
18
Mar 2020

Consultant
John Larkin
Report
8
Aug 2023
In line with international deal activity, Ireland’s mergers and acquisitions (M&A)...

Partner
Stephen Keogh
prev
next