MDR
New Notified Body
The 14th notified body under the MDR was officially designated:
Intertek Medical Notified Body AB (NB 2862) was approved to perform medical device certification under the MDR 2017/745. The Swedish conformity assessment body offers a range of certification for non-implantable active and non-active devices and also e.g. for devices incorporating medicinal substances.
MDCG updates
- A new Manufacturer Incident Report (MIR) was published e.g. with changes due to the new IMDRF codes, several fields been made auto-expandable and bugfixes.
- MIR form
- MIR for importing XML file with Adobe Professional 2020
- FAQ regarding the implementation of the new MIR form
- Changelog file
- New guidance document (MDCG 2020-10/1) was released concerning the safety reporting in clinical investigations of medical devices
- with an additional guidance (MDCG 2020-10/2) on the clinical investigation summary safety report form
- The status of the ongoing guidance activities of the MDCG was published here:
Other news
The EU released guidelines on the adoption of Union-wide derogations for medical devices to help to determine whether a national derogation for a certain medical device could be of Union relevance.
COVID-19
Singapore
Singapore’s HSA (Health Sciences Authority) published a guidance on 3-D printing of essential medical devices and accessories for use in COVID-19. Critical medical devices are short in supply due to the increased demand in this pandemic and 3-D printing those devices is supposed to fill in those gaps.
USA
The FDA published a new guidance document about the postmarketing adverse event reporting for medical products during a pandemic.
Also the FDA starts resuming the inspections after their halt due to the pandemic.
Russia
Russia released a resolution that simplifies the approval process for medical devices urgently needed to fight COVID-19. The new process can be applied to 108 medical devices and IVD products listed in the resolution.
A governmental institution published a guideline for the simplified approval process.
Kazakhstan
Also Kazakhstan simplified the approval process for medical devices intended for emergency use.
Brazil
ANVISA published a norm regulating the import of intensive care unit equipment such as ventilators, vital signs monitors, and infusion pumps.
Canada
On their website, the Canadian government is feeding medical device manufacturers, distributors and health professionals with lots of information in relation to COVID-19 such as exceptional importation and sale of medical devices and Medical device shortages.
Malaysia
There has been a change on the special access procedure for medical device: The Medical Device Authority (MDA) will no longer consider special access notification through Route A. The guidance document MDA/GD/0043 contains the relevant requirements.
China
Standards revision plan 2020
CFDA published a document containing a list of 86 medical device industry standards that they plan to revise this year. Main focus is on the following fields (but not limited to):
- Devices with artificial intelligence
- General and specific IVD standards
- Biocompatibility
- Surgical implants
- Imaging devices
- Active respiratory devices
- Reliability of active devices
- Cybersecurity
- Dental science
- Ophthalmology
All updates compiled in one PDF file:
You can download all Regulatory Affairs Updates compiled for you as a PDF under the following link.
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