Back in August, we have issued an article about a new guidance document published by the Medical Device Coordination Group (MDCG), MDCG 2021-21. The guidance document lays out specific requirements… Read More
SARS-CoV-2 IVD tests and the IVDR
Category: COVID-19
The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD
The Medical Device Coordination Group (MDCG) has published guidance MDCG 2021-21 “Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices” – the document is critical for all manufacturers… Read More
Guidance document on the impact of genetic variants on SARS-COV-2
The Medical Device Coordination Group (MDCG) has issued a guidance document MDCG 2021-7 for manufacturers of in vitro diagnostic medical devices that relate to SARS-CoV-2. The scope is defined as… Read More
Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons
Germany has updated its legislation and allows for special admissions of antigen tests for self-administration by laypersons (self-tests) for the detection of SARS-CoV-2. The common conformity assessment procedure for self-test… Read More
European Commission publishes Q&A guidance on COVID-19 tests
The European Commission has recently published Q&A guidance on COVID-19 tests in the EU. The regulatory context of this document is Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)… Read More
Defined performance criteria for rapid SARS-CoV-2 antigen tests
It is commonly known that COVID-19 IVD tests may be CE marked under annex III of the IVD Directive without the involvement of a Notified Body. To nonetheless increase supervision,… Read More
Update from the European Commission for protective equipment in the COVID-19 crisis
The European Commission has updated its Q&A document on conformity assessment procedures for protective equipment like face masks, gloves, coveralls, etc. The corresponding document can be downloaded here. Furthermore, the… Read More
COVID-19 In Vitro Diagnostic Devices and Test Methods Database available
Back in April, 2020, the European Commission has committed itself to set up a database of CE marked COVID-19 IVD tests. The Commission has now published a link under which… Read More
European Commission guidance on surgical masks
mdi Europa has been contacted frequently throughout the COVID-19 crisis regarding regulatory requirements for surgical masks in Europe under Directive 93/42/EEC (MDD) and Regulation (EU) 2017/745 (MDR) on medical devices.… Read More
Surgical and FFP masks in the COVID-19 crisis
The German Federal Institute for Drugs and Medical Devices (BfArM) has specified on its website the provisions for this special route, which follows Recommendation (EU) 2020/403 from March 13. The article… Read More
European Commission gives details of how to prevent COVID-19 test failures
The European Commission has published a derogatory report on the level of evidence available for COVID-19 tests – RNA, antigen and antibody tests – arriving on the market. It explains… Read More
Guidance on MD and PPE in times of COVID-19 and local provisions
The European Commission has continued to work on guidance for manufacturers and other economic operators of medical devices and personal protective equipment (PPE) to provide answers on specific questions that… Read More