The intended use statement of medical devices is a central aspect in the European regulatory environment. The intended use drives the requirements a device must fulfill. This has already been… Read More
The European Commission has put another item on its already long list of guidance documents for medical device manufacturers. MDCG 2021-24, Guidance on classification of medical devices, will probably be… Read More
The European Commission has announced recently that the EUDAMED UDI/Devices and NBs and Certificates modules are now ready. Specifically, the UDI/Devices module is probably of interest for many manufacturers as… Read More
Back in 2019, the Medical Device Coordination Group (MDCG) published guidance MDCG 2019-6, a Q&A document related to requirements around notified bodies. The Commission has now issued revision 3 of… Read More
Notified body bsi has published an article in February in the Journal of Medical Device Regulation. In this article, bsi is sharing insights on its perspective on how manufacturers should… Read More
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
Team-NB, the European Medical Devices Notified Body Association, published a position paper on the applicability of implant cards as required under Regulation (EU) 2017/745 on medical devices (MDR). Readers should… Read More
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
