The section below is intended for all parties who are involved in the manufacturing of medical devices including in vitro diagnostic medical devices. You will find more than 50 important… Read More
Complete Download Section mdi Europa
Complete Link Section mdi Europa
The section below is intended for all parties who are involved in the manufacturing of medical devices including in vitro diagnostic medical devices. You will find an up to date… Read More
Certificates of Free Sale
We can help you to enter different markets worldwide – with Free Sales Certificates for your medical device or In vitro diagnostic products! Many countries outside of the European Union… Read More
bsi develops guidelines for the application of ISO 14971 to artificial intelligence and machine learning
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 IVDR and performance evaluation studies
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
New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR
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
Insufficient sterilization of medical devices by Steril Milano S.r.l
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
Guidance documents on clinical investigation applications, UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers, implant cards and EMDN
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
EU UDI helpdesk available
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
Standard ISO 20417:2021 for the MDR and IVDR published
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
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
EU clearance for MDR and IVDR harmonised standards
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
EU – Switzerland MRA expired
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
Guidance on legacy devices regarding Eudamed
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
New guidance documents published by the European Commission
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
IVD or not IVD? That is the question…
…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
Updated EUDAMED implementation dates
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
MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality
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
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
Supportive Information Section mdi Europa
Below we listed a collection of useful documents to support your compliance process. These have been compiled by or on behalf of mdi Europa and are thus not available free… Read More
Voluntary registration with EUDAMED database – industry fears duplicate registrations
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
Additional MHRA guidance for medical device companies
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
mdi Europa experience on MDR technical documentation reviews
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
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
Key guidance document on the classification of IVDs under the IVDR
The European Commission has published a key guidance document on the classification of in vitro diagnostic medical device (IVD) under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)… Read More
EU IVD medical devices sector destined for crisis?
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
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
Sufficient clinical evidence under the MDR for class I legacy devices
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
New website on actor registration in EUDAMED 3 available
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
Latest UK MHRA updates on Northern Ireland and EU device regulation guidance
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
Practical advice for setting up an MDR and IVDR compliant PMS Plan
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
Get ready for the economic operator registration in EUDAMED
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
Regulation on market surveillance and compliance of products requires EU Authorized Representative for additional legislations
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
New UKCA mark after Brexit
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