Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Swedish language law allows few exceptions:

This article was originally published in Clinica

Executive Summary

Sweden's National Board of Health and Welfare has clarified the circumstances under which labelling of CE-marked medical devices used in Sweden can be in languages other than Swedish. An article in Clinica No 862, p 14 said the use of English was possible in some circumstances. Under the medical device regulations, labelling and instructions for use must be in Swedish, regardless of whether the user is a patient or health professional or whether the device is used in hospital or in a home setting. The board may exempt from the general language requirements specific products which would be used where there are "no other options to cope with a specific medical situation in a satisfactory manner".

You may also be interested in...



Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development

Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.

Investors Go Berserk For Viking, Putting It Top Of Q1 Winners

The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.

EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications

Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT075939

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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