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
Press Relations Legal and Home Affairs Working Group, Ireland; Communications Strategy
Phone: +32 475 957 874
Thomas Bickl
Press Relations Germany and Luxembourg
Phone: +32 478 215 372

Latest

EU future, terror financing, journalist murders, Facebook scandal
19.04.2018 - 12:45

EU future, terror financing, journalist murders, Facebook scandal

The European Parliament debated the French President’s future-minded EU reform ideas with the EPP Group calling for greater security for...
Money laundering
19.04.2018 - 11:07

Tough rules against terror money and tax evasion

New money laundering rules also apply to virtual currencies "Shady money transactions will become much more difficult. The financial system...
Jan Kuciak's commemoration
19.04.2018 - 09:46

What has the Slovak Government done to protect journalists

Today, the plenary of the European Parliament (EP) paid tribute to the memory and legacy of investigative journalist Ján Kuciak and his fianc...
Exhaust pipe
18.04.2018 - 16:15

European Parliament stops Dieselgate from happening again

"The public rightly expects us to fix the Dieselgate loopholes." Ivan Štefanec MEP, EPP Group Spokesman on Type Approval “I...

Highlights of the week

23.04.2018 - 27.04.2018
Construction workers working on cement formwork frames

Towards new rules on the posting of workers

Members of the Employment Committee will vote on the final agreement between the Commission, the Parliament and the Council on the revision of the...
Flowers and car

Action needed to combat mileage fraud in Europe

The Transport Committee will demand action from the European Commission on mileage fraud in Europe on Wednesday. In cross-border car sales, research...
Photo of ready meals containting meat

Dual quality products in the Single Market

As a consumer in the EU, you have the right to be treated equally with others. A high-level conference to discuss the discriminatory practice of dual...
Believe in People campaign, Ivan Dell'Orco