Mondaq Europe: Food, Drugs, Healthcare, Life Sciences
The medical devices sector covers a wide range of products, from simple bandages to highly sophisticated devices such as pacemakers, as well as contact lenses, prostheses, medical equipment for hospital use, etc.
On April 26 2012 Regulation No 380/2013 was published in the Official Journal, amending Regulation No 1141/2010 which lays down the procedure for the renewal of the inclusion of active substances in Annex I to Council Directive 91/414.
The Finnish Medicines Act is proposed to be amended by Government bill.
A dsiscussion on the amendments proposed to the Finnish Medicines Act.
The French Sunshine Act - probably one the longest-awaited decrees in recent French regulation.
The European Lawyer Reference Series: Guide to the Distribution and Marketing of Drugs 2013 provides practical information on the sale, promotion, distribution and marketing of drugs in an easy-to-read "question and answer" format.
What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?
European rules on the tagging of bovine animals and on voluntary labelling of beef products are set to change in the near future.
With the ever increasing media focus on the responsibilities and duties of health and social care professionals, Rebecca Ryan and Grace Keegan review the processes to be put in place by Ireland’s first multi-profession regulator
There has been a significant increase in the use of social media platforms in medicine and healthcare over the past number of years.
The introduction of generic substitution and reference pricing has received widespread media attention.
On 10 January 2013 the landmark case brought by Ms Fleming, challenging the constitutionality of the absolute ban on assisted suicide under section 2 (2) of the Criminal Law (Suicide) Act 1993, was unanimously rejected by the High Court.
CORU is responsible for regulating 12 different health and social care professions, and has the responsibility for promoting high standards of professional conduct and education.
Mr Flynn injured himself in 1987 by pressing the back of his palate with his finger, which caused him severe pain and difficulty swallowing.
In December 2010, Dr T was found guilty of professional misconduct following a three day fitness to practise hearing at the Medical Council.
The Dental Complaint’s Resolution Service (the "DCRS"), located in Mayo, is up and running since May 2012.
The Government recently approved the creation of new law which will provide an alternative to large, once off awards in cases involving catastrophic injuries.
In an unprecedented and landmark High Court judgment on 5 March 2013, Judge Abbott has declared that the genetic mother of twins born to a surrogate is entitled to be recognised as their legal mother.
A discussion on the recently introduced EU Falsified Medicines Directive.
An overview of the impact of the EU proposal for regulating medical devices in the field of active implantable devices.
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The French Sunshine Act - probably one the longest-awaited decrees in recent French regulation.
This article is designed to provide a brief introduction to the requirements for licensing, importing, and introducing pharmaceutical products to the Turkish market.
In Turkey, the medical device market has been expanding steadily over the past decade in line with the general growth trend in the healthcare service sector.
An overview of the impact of the EU proposal for regulating medical devices in the field of active implantable devices.
In the case "Brain Products GmbH v BioSemi VOF" the Court of Justice for the European Union has clarified the meaning of ‘medical device’.
The new Health and Safety Regulations 2013 come into force on 11 May 2013, and it was built on existing law and provides specific detail on requirements that must be undertaken by healthcare employers and their contractors.
Following publication of the results of the Intellectual Property Office’s consultation on the subject, the Government has announced that the Patents Act shall be amended.
We have advised recently on a number of incidents where it is alleged that a doctor was criminally responsible for the death of his/her patient.
In GDC v Lorna Jamous, the High Court has just held that tooth-whitening is a treatment that is "usually" performed by dentists and therefore cannot lawfully be carried out by unqualified people.
A discussion on the conduct of clinical trial in the European Union.
