Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Seven Types Of Scrutiny: A Tangled And Costly Web Ahead For Device Makers

This article was originally published in SRA

Executive Summary

The 'scrutiny' procedure of high-risk devices is one of the most controversial points in the proposed EU regulations for medical devices and IVDs. But medtech manufacturers look to be facing not just one but seven types of regulatory scrutiny across the two proposed regulatory texts. Moreover, the different scrutiny procedures could apply cumulatively to some products. In the Q&A below, medtech regulatory expert, Gert Bos, explains why this matter needs to be addressed urgently.

You may also be interested in...



UK-Based GMDN Endorsed As US Preferred Method For Categorizing High-Risk Implants

While the EU has selected the CND system as the basis for its nomenclature, GMDN is becoming increasingly valued on the US and international scene. How does it see its latest role panning out globally?

Commission Provides Latest Notified Body Figures: How Does Update Help Industry?

Updated medtech notified body figures from the European Commission always make headline news. But industry needs to see real appointments now, not a list of tricky-to-understand numbers.

Medicinal Products Expert And Established Devices Leader Head Commission’s Medtech Unit

Erik Hansson remains deputy head of devices in a move to the European Commission’s DG Sante from DG Grow. He now answers to a newly appointed devices head who shares a common educational background but whose recent pharmaceutical role may unsettle the devices industry.

UsernamePublicRestriction

Register

MT040737

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel