European Medical devices regulation

Female patient and male doctor.jpg

Opinion of the European Economic and Social Committee on the 'Pro

European Parliament and of the Council on Medical Devices and amending

Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 »

COM (2012) 542 final - 2012/0266 (COD)

to

'Proposal for a Regulation of the European Parliament and of the Council concerning medical devices

in vitro diagnostic »

COM (2012) 541 final - 2012/0267 (COD)

and

'Communication from the Commission to the European Parliament, the Council, the European Economic and

Social Committee and the Committee of the Regions - Medical devices and diagnostic medical devices in

vitro safe, effective and innovative products for the benefit of patients, consumers and healthcare professionals'

COM (2012) 540 final

(2013 / C 133/10)

Rapporteur:

STANTIČ

The Council, on 15 October 2012, and the European Parliament, on 22 October 2012, they decided,

accordance with the provisions of Articles 114 and 168, paragraph 4, letter c) of the Treaty on the Functioning

European Union (TFEU), to consult the European Economic and Social Committee on the:

Proposal for a Regulation of the European Parliament and of the Council on Medical Devices and amending

Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009

COM (2012) 542 final - 2012/0266 (COD).

and

Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices

COM (2012) 541 final - 2012/0267 (COD).

The Commission, on 26 September 2012, has decided, under Article 304 of the

Treaty on the Functioning of the European Union, to consult the European Economic and Social Committee

on the:

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the

Committee of the Regions - Medical devices and in vitro diagnostic medical devices safe, effective and innovative

benefit of patients, consumers and healthcare professionals

COM (2012) 540 final.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the Committee's work

on the subject, adopted its opinion on 5 February 2013.

At its 487

to

plenary session, held on 13 and 14 February (meeting of 14 February 2013), the Committee

Economic and Social Committee adopted the following opinion by 136 votes in favor and 5 abstentions.

1.Conclusions and recommendations

1.1

The European Economic and Social Committee (EESC) in oil

nea that health has a high priority for citizens

European and reiterates thatmedical devices (MD) (

1

) Anddevices

medical in vitro diagnostic (IVD) (

2

) Play a key role

that on the prevention, diagnosis and treatment of

diseases.They are essential for our health and the quality

of life of those who suffer and are struggling with diseases and

disabilities.

IT

C 133/52

Official Journal of the European Union

(

1

) Medical devices include products such as bandages, contact lens


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2013-03-20 12:19:34 by flaveur

"Obamacare" ..jobs destroyed in NY, WI, MA, etc.

Smith & Nephew Orthopedics is laying off an estimated 100 employees in Memphis and Andover, Mass., citing the 2.3% excise tax on orthopedic device companies as the reason.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
The company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013

2013-03-20 12:20:55 by flaveur

Um, it's actual closings and layoffs. Hello?

Smith & Nephew Orthopedics is laying off an estimated 100 employees in Memphis and Andover, Mass., citing the 2.3% excise tax on orthopedic device companies as the reason.
Medical Device Tax: Cook Medical scuttles midwest expansion plans over levy
Cook Medical says it will not proceed on plans to open 5 new facilities in the midwest because of concerns about the medical device tax.
The company will likely pay between $20 to $30 million once the 2.3% excise tax takes effect in January, 2013

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