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Media Centre >> News >> Medical Devices | Monthly bulletin | September 2019

Medical Devices | Monthly bulletin | September 2019

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Friday, September 20, 2019

Eurofins newsflash Medical Device

 

Europe

 

Recent publications by European Commission

 

Below you will find a draft act recently published in the Official Journal of the European Union related to Medical Devices:

 

Date

Reference

Title

26-7-2019

Document Ares(2019)4763425

Draft act:

 

COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use medical devices

 

Regulatory proposals notified to WTO

 

Below a summary table with some recent notifications to World Trade Organization (non-exhaustive):

 

Notification number / Link

Title

G/TBT/N/EU/673

Draft Commission Implementing Decision amending Decision 2002/364/EC as regards definitions of first-line assays and confirmatory assays, requirements for devices for self-testing and requirements for HIV and HCV rapid tests, confirmatory and supplementary assays

 

Europe/International

 

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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

IEC Standards

Reference

Title

Publication date

IEC 80601-2-77:2019

Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

2019-07-09

IEC 80601-2-78:2019

Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

2019-07-09

CEN/CENELEC

Reference

Title

Date of Withdrawal (*)

Supersedes

EN ISO 16054:2019

Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)

2020-01-31

EN ISO 16054:2002