Medical Devices | Monthly bulletin | September 2019
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 |
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 |
|
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 |
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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.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 |
|
|
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
2019-07-09 |
||
|
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 |
|
Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019) |
2020-01-31 |
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