Press Release

Safer medical products for Europeans

Strasbourg
, 05.04.2017 - 12:42
Defibrillator

The European Parliament adopted tougher EU standards on medical products today. There will be tighter controls of the safety of products, such as breast implants, not only prior to authorisation, but also as unannounced inspections later at the production sites. A passport will accompany all types of medical implants to make them safer. Furthermore, mandatory counselling ahead of sensitive medical tests will be introduced. The new rules have already been agreed on between Parliament and Council.

"After four years of intense negotiations, the European Parliament has given its final approval to new measures aimed at improving patient safety while encouraging innovation in the sector to ensure that new developments in medical devices can come on to the market. It is absolutely essential that this new Regulation, which is quite complex, is implemented correctly across the EU. For that to happen, the European Commission must assign adequate resources to monitor its application and Member States also need to ensure that their industry complies", said Mairead McGuinness MEP who is in charge of the Medical Products Regulation for the EPP Group.

"A few weeks ago, the European Court of Justice ruled on the case of the scandal involving PIP’s harmful breast implants. The court determined that until now, notified bodies were not obliged to conduct inspections at company premises. This is going to change with the new EU legislation", said Peter Liese MEP who is the EPP Group Spokesman on the Environment and Health Committee.

The new standards also apply to in-vitro diagnostic medical devices. HIV or DNA tests will be subject to tight controls prior to and after authorisation. In addition, sensitive tests such as on the DNA of embryos will come with a mandatory consultation by a specialist.

"Such sensitive tests may seriously affect a patient's life and they should not be carried out without informing the patient of the consequences of the test. There is also an ethical dimension to it", said Liese who is also the European Parliament Rapporteur on the EU Regulation on in-vitro diagnostic devices.

The new EU rules have been agreed on between Parliament and Council and will enter into force by mid-2020. "The negotiations on the new standards have taken a long time. It is good news that we now have a balanced agreement which can also help boost innovative medical devices in the EU", concluded Peter Liese MEP.

Note to Editors
The EPP Group is the largest political group in the European Parliament with 216 Members from 27 Member States

MEP Contacts

-
Mairead McGUINNESS
STR - Phone: +33 (0)3 88 175214 Fax: +33 (0)3 88 179214
Email: mairead.mcguinness@europarl.europa.eu
-
Peter LIESE
STR - Phone: +33 (0)3 88 175981 Fax: +33 (0)3 88 179981
Email: peter.liese@europarl.europa.eu

Press Contacts

Cliona Connolly
Irish press; Communications Strategy; Intercultural and religious dialogue
Phone: +32 475 957 874
Thomas Bickl
German & Luxembourgish press
Phone: +32 478 215 372

Latest

CETA
20.09.2017 - 10:42

Europe leads on rules-based trade: CETA comes into force

Following seven years of negotiations, the Comprehensive and Economic Trade Agreement (CETA) will provisionally enter into force tomorrow. "The...
Euro symbol in the magnifying glass
14.09.2017 - 12:41

EPP Group deplores attempts to keep NGO financing secret

In a vote today the EPP Group rejected attempts to keep NGO financing a secret. Hiding behind calls for transparency in this House, the Greens and...
State of the Union, Fipronil scandal, Turkey, Venezuela
14.09.2017 - 12:00

State of the Union, Fipronil scandal, Turkey, Venezuela

At the European Parliament’s latest plenary, European Commission President Jean-Claude Juncker proposed plans to strengthen the EU27 as Brexit...
Germany Raises Security Level
14.09.2017 - 11:06

Committee on terrorism: new European approach to security

The new European Parliament Committee on Terrorism (TERR), initiated by the EPP Group, met for the first time today. It will have one year to assess...

Highlights of the week

25.09.2017 - 29.09.2017
European Ideas Network

EIN: debating the future of common security and stability in the Mediterranean

'Common Security and Stability in the Mediterranean Region' is the main subject of the European Ideas Network's (EIN, the EPP Group's...
Gavel and european union flag

Setting up the European Public Prosecutor’s Office

The proposal to establish a European Public Prosecutor’s Office will be voted on in the Committee on Civil Liberties, Justice and Home Affairs...
Construction worker doing measuring

The Services Package - an alternative to enforcement action?

Services represent two-thirds of the EU economy already and about 90% of job creation - for around 47 million people (22% of the European labour...
The Narnia Project