bsi announced that it started public consultation for BS AAMI 34971 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning. The document is intended to provide… Read More
The date of application for Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) is approaching quickly. As of May 26, 2022, all manufacturers of IVD medical devices will have to… Read More
The Medical Device Coordination Group (MDCG) has issued another guidance document. MDCG 2021-10 references certain principles and terminology used in appendices E – I of the IMDRF N48 guidance document… Read More
The Federal Institute for Dugs and Medical Devices (BfArM) in Germany has issued a notice where it informs manufacturers and users about the inadequate sterilization of medical devices by Steril… Read More
The Medical Device Coordination Group (MDCG) has issued new guidance documents under Regulation (EU) 2017/745 on medical devices (MDR): MDCG 2021-08 lays out application mechanisms including application forms for clinical… Read More
Just recently, the European Commission launched a new helpdesk website for EU UDI related questions under Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices… Read More
EN 1041:2008 is the harmonized standard for information to be supplied by medical device manufacturers. The International Standardization Organization (ISO) has recently published ISO 20417:2021, which will replace EN 1041… Read More
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
The EU has approval to adopt and list standards that will be recognised under Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and… Read More
The European Commission issued an article that announces the expiration of the EU-Switzerland Mutual Recognition Agreement (MRA). The article says: “The Mutual Recognition Agreement (MRA) is one of the key… Read More
Legacy devices are products that have been CE marked in the context of the current Directives but not under Regulations (EU) 2017/745 and 2017/746 on medical devices or in vitro… Read More
The date of application of Regulation (EU) 2017/745 on medical devices (MDR) is approaching and the European Commission has issued new and updated guidance documents. Please find below a list… Read More
…for many manufacturers of products for general laboratory use like pipettes, centrifuges, thermocyclers or glass microscope slides. Some manufacturers are in the mistaken belief, that their device is regulated by… Read More
The European Commission has updated the planned implementation timelines for the gradual introduction of the corresponding modules. The actor registration module went live on December 1, 2020. Until the more… Read More
The Medical Device Coordination Group (MDCG) has issued a new guidance document MDCG 2021-1, Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional. The document… Read More
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
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
The first module of the EU medical device database, EUDAMED, is up and running. However, because actor registration is voluntary until 26 May 2022, when the complete database is planned… Read More
Several guidance documents have been published by the Medicines and Healthcare products Regulatory Agency (MHRA) in December 2020 and subsequently, including guidelines on the UK Responsible Person (UKRP) and UK… Read More
Under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), EU Authorized Representatives are – among others – in charge of… Read More
BfArM informs about damages to hip implants caused by high-frequency cauterizing instruments BfArM, the German Federal Institute for Drugs and Medical Devices, has issued a recommendation in connection with high-frequency… Read More
The European Commission has fallen behind when it comes to providing guidance and structures required to support the in vitro medical devices sector in timely compliance with Regulation (EU) 2017/746… Read More
This article discusses the major aspects covered by the guidance document MDCG 2020-6, Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC, herein referred to… Read More
In August 2020, the Medical Device Coordination Group (MDCG) announced that the economic operator registration or actor registration module will be available as of December 1, 2020. This module will serve… Read More
Medtech Insight has just recently published an article on the updated guidance from for the post-Brexit era. The Medicines and Healthcare products Regulatory Agency (MHRA) issued a guidance update on… Read More
Till date, neither the European Commission nor a related organization has issued an official guidance document on the medical devices regulation (MDR) and in vitro diagnostic medical devices regulation (IVDR)… Read More
In a recent article we have reported that the EUDAMED economic operator registration module will be available as of December 2020. The corresponding registration will trigger the assignment of a… Read More
Did you know that the European Commission has issued Regulation (EU) 2019/1020? This regulation on market surveillance and compliance of products lays out updated requirements on the appointment of EU… Read More
On September 1, 2020, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a new guidance how medical devices will be regulated post-Brexit as of January 1, 2021.… Read More
Last year, the European Commission has announced that EUDAMED 3 as one central aspect for the implementation of important medical devices regulation (MDR) and IVD regulation (IVDR) mechanisms, will not… Read More
The European Commission has issued a document that is highly relevant for manufacturers of reusable and resterilizable medical devices. You can find this document here. The background for issuing this… Read More
The European Commission’s “State of play of joint Implementation plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR”, which… Read More
The Medical Device Coordination Group (MDCG) has issued a guidance document that is intended to streamline audit processes and efforts under the medical devices regulation (MDR) and IVD regulation (IVDR).… Read More
