REGULATORY NEWS

July 27, 2020

The Government of the Slovak Republic approved a temporary version of the regulation on technical requirements and conformity assessment procedures for active implantable medical devices. This version of the regulation is going to be effective from June 23, 2020 to May...

July 21, 2020

The Ministry of Environment and Food of Denmark issued Order No. 947 “On restriction of Phthalates in toys and toddler products” dated by June 20, 2020

According to this Order, it is forbidden to use phthalates in manufacturing of toys and products for toddlers or par...

May 13, 2020

The European Commission adopted Regulation (EU) 2020/561 on April 23, 2020. This Regulation amends Regulation (EU) 2017/745 on medical devices and postponed the dates of its application.

Initially, the MDR was meant to come into force from May 26, 2020. The MDR is more...

April 29, 2020

New lists of harmonized standards was published in the Official Journal of the EU on March 25, 2020. 

The lists relate to the three Directives on medical devices: 

  • Council Directive 93/42/EEC of June 14, 1993 concerning medical devices

  • Council Directive 90/...

April 1, 2020

All medical devices to be placed on the EU market must have a CE mark. Thus, a medical device must meet requirements of the EU ruling documents. The Directives 90/385/EEC and 93/42/EEC were used previously. However, EU MDR was established in 2017 and preliminary should...

March 12, 2020

The European Commission released Commission Regulation (EU) 2019/2021 of 1 October 2019 on “Ecodesign requirements for electronic displays”. This regulation is pursuant to Directive 2009/125/EC of the European Parliament and of the Council. It amends Commission Regulat...

October 31, 2019

Every Halloween millions of people dress up in fancy costumes to trick or treat everybody around them. However, nobody cares about the danger behind these funny and innocent jokes associated with unsafe, low-quality or flammable clothes and other related stuff. 

As a ma...

October 23, 2019

Manufacturers and importers should take into consideration that the Directive 2009/48/EC of the European Parliament and of the Council of June 18, 2009 on the safety of toys is amended with regard to the limit value for Chromium VI and harmonized standards. 

The Europea...

October 10, 2019

On August 8, 2019, the EU Commission adopted two Pack 14 delegated Directives amending Annex III of Directive EU 2011/65/EU on “the Restriction of the use of certain hazardous substances in electrical and electronic equipment”.

The EU RoHS Directive 2011/65/EU (also kno...

October 4, 2019

On December 10, 2015, the German Parliament adopted a law amending the Federal Energy Labelling Act 2002 in an effort to promote the replacement of old heaters with new more energy-efficient models.

The law also aims to implement European Delegated Regulations (EU) No 8...

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