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Media Centre >> News >> Eurofins | April 2019 regulatory Newsflash compilation | Medical Device

Eurofins | April 2019 regulatory Newsflash compilation | Medical Device

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Tuesday, April 9, 2019

Eurofins newsflash Medical Device




Public consultation on phthalates in medical devices


On 18th 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 covering phthalates, which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties.


This public consultation is open until 29th April 2019.


Deadline for comments on phthalates to update Annex XIV to REACH


12th March 2019 was the deadline for comments for draft recommendation on four phthalates and their endocrine disrupting properties by ECHA (European Chemical Agency).


The aim is to update Annex XIV (Authorisation List) to REACH Regulation (EC) No 1907/2006 concerning the following four phthalates to include their endocrine disrupting properties:


  • Bis (2-ethylhexyl) phthalate (DEHP No. CE204-211-0, CAS No. 117-81-7)
  • Dibutylphthalate (DBP, EC No. 201-557-4, CAS No. 84-74-2)
  • Benzylbutylphthalate (BBP, CE No. 201-622-7, CAS No. 85-68-7)
  • Diisobutylphthalate (DIBP, no. CE201-553-2, CAS84-69-5)

Some previously exempted uses may require an application for authorization following this update of Annex XIV. The public consultation targets, in particular, the operators concerned by these uses, namely: use in mixtures between 0.1 and 0.3%, use in materials in contact with foodstuffs or in medical devices.




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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.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 IEC 62464-1:2019

Magnetic resonance equipment for  medical imaging - Part 1: Determination of essential image quality parameters.


EN 62464-1:2007

EN ISO 7886-4:2019

Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2018).


EN ISO 7886-4:2009