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Media Centre >> News >> Eurofins | June 2019 regulatory Newsflash compilation | Medical Devices

Eurofins | June 2019 regulatory Newsflash compilation | Medical Devices

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Wednesday, June 5, 2019

Eurofins newsflash Medical Device




Last scientific committees’ news on phthalates in medical devices


As already announced in our Eurofins News Flash April 2019 edition, in March 2019, the European Commission and its SCIENTIFIC COMMITTEE ON HEALTH, ENVIRONMENTAL AND EMERGING RISKS (SCHEER) opened a Public consultation on the Preliminary Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices.


This public consultation was closed on 29th April 2019. But before that date, on 4th April 2019, the European Commission and SCHEER organised a hearing on this matter with the aim to compile comments, suggestions, explanations and contributions complementing the public consultation.


Click here for getting the summary records and presentations about this hearing from European Commission website.


Recent publications by European Commission


Below you will find the corrigendum published in the Official Journal of the European Union related to Medical Devices.







Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.




Standards Updates


Below a summary table with some recent standards updates and upcoming dates of withdrawal (non-exhaustive):


(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.




Date of Withdrawal (*)


EN ISO 11138-7:2019

Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019).


EN ISO 14161:2009




FDA List of Accessories suitable for Class I


The US Food and Drug Administration (FDA) has recently notified to World Trade Organization the following:


Notification number / Link




US Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I.