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Complete Download Section mdi Europa

December 21, 2020
by 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 more than 40 important… Read More

Filed under CE Marking, Download Section Service, Guidance Documents, IVDR Service, Legislation Documents, Library, MDR Service
Tagged Guidance Documents, IVDR, MDR

Complete Link Section mdi Europa

August 16, 2019
by 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

Filed under CE Marking, EU Authorized Representative, IVDR Service, Library, Link Section Service, MDR Service

Certificates of Free Sale

September 13, 2018
by Oliver Giesemann

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

Filed under CE Consulting, Certificates of Free Sale, EU Authorized Representative
Tagged Certificates of Free Sale, Certificates of Free Sales

mdi Europa experience on MDR technical documentation reviews

January 14, 2021
by Michael Sander

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

Filed under Important Notice, MDR, News in Brief
Tagged MDR

BfArM informs about damages to hip implants

December 13, 2020
by Michael Sander

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

Filed under News in Brief
Tagged BfArM, Medical Devices, News in Brief, Security Advice

Key guidance document on the classification of IVDs under the IVDR

December 1, 2020
by Michael Sander

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

Filed under Important Notice
Tagged Guidance Documents, IVDR, MDCG

EU IVD medical devices sector destined for crisis?

November 6, 2020
by Michael Sander
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!

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

Filed under IVDR, News in Brief
Tagged IVDR, Notified Body

Defined performance criteria for rapid SARS-CoV-2 antigen tests

November 5, 2020
by Oliver Giesemann

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

Filed under COVID-19
Tagged COVID-19

Sufficient clinical evidence under the MDR for class I legacy devices

November 3, 2020
by Michael Sander

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

Filed under Important Notice, MDR, News in Brief
Tagged Clinical Evaluation, Guidance Documents, MDCG, MDR

New website on actor registration in EUDAMED 3 available

October 29, 2020
by Oliver Giesemann

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

Filed under IVDR, MDR, News in Brief
Tagged EUDAMED, IVDR, MDR

Latest UK MHRA updates on Northern Ireland and EU device regulation guidance

October 26, 2020
by Sheila OShaughnessy

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

Filed under Brexit, News in Brief
Tagged Brexit, No-Deal Brexit

Practical advice for setting up an MDR and IVDR compliant PMS Plan

October 22, 2020
by Michael Sander

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

Filed under IVDR, MDR, News in Brief
Tagged IVDR, MDR

Get ready for the economic operator registration in EUDAMED

October 9, 2020
by Oliver Giesemann

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

Filed under IVDR, MDR, News in Brief
Tagged EUDAMED, Guidance Documents, IVDR, MDCG, MDR

Regulation on market surveillance and compliance of products requires EU Authorized Representative for additional legislations

October 7, 2020
by Sheila OShaughnessy

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

Filed under News in Brief
Tagged EU Authorised Representative, EU Authorized Representative

New UKCA mark after Brexit

September 17, 2020
by Sheila OShaughnessy

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

Filed under Brexit, News in Brief
Tagged Brexit, No-Deal Brexit

EUDAMED economic operator registration module available as of December 2020

September 16, 2020
by Oliver Giesemann

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

Filed under IVDR, MDR, News in Brief
Tagged EUDAMED, Guidance Documents, IVDR, MDCG, MDR

Guidance checklist for manufacturers of reusable and resterilizable medical devices

September 3, 2020
by Michael Sander

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

Filed under News in Brief
Tagged Guidance Documents, MDD

Commission to put forward another European standards request

August 24, 2020
by Michael Sander

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

Filed under MDR, News in Brief
Tagged European Commission, MDR

New guidance document shows how to use MDSAP audit reports for MDR/ IVDR surveillance audits

August 21, 2020
by Michael Sander
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!

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

Filed under IVDR, MDR, News in Brief
Tagged Guidance Documents, IVDR, MDCG, MDR

Updated Q&A document on MDR and IVDR UDI requirements from the European Commission

August 12, 2020
by Oliver Giesemann

The European Commission has updated its Q&A document on UDI requirements under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The paper provides answers to… Read More

Filed under IVDR, MDR, News in Brief
Tagged Guidance Documents, IVDR, MDR, UDI, Unique Device Identification

ISO TR 20416 and PMS under the MDR

August 1, 2020
by Michael Sander
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!

According to article 84 and annex III of Regulation (EU) 2017/745 on medical devices (MDR), manufacturers must draw up a Post-Market Surveillance (PMS) Plan. As mentioned in previous articles, PMS… Read More

Filed under MDR, News in Brief
Tagged MDR

EU guidance on Notified Body clinical evaluation assessment reports

July 24, 2020
by Michael Sander

The European Commission’s Medical Devices Coordination Group (MDCG) has issued a guidance document outlining the role of the Notified Body’s clinical evaluation assessment report (CEAR) in assessing a device under… Read More

Filed under Important Notice, News in Brief
Tagged Clinical Evaluation, Guidance Documents, MDCG, MDR

Update from the European Commission for protective equipment in the COVID-19 crisis

July 20, 2020
by Oliver Giesemann

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

Filed under COVID-19, News in Brief
Tagged COVID-19

COVID-19 In Vitro Diagnostic Devices and Test Methods Database available

July 2, 2020
by Oliver Giesemann

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

Filed under COVID-19, News in Brief
Tagged COVID-19

Relocation of the European Commission website on medical devices

June 30, 2020
by Oliver Giesemann

In summer 2019, mdi Europa has reported that the European Commission has restructured its website on medical devices. Since then, manufacturers could retrieve valuable information about EU regulatory requirements under… Read More

Filed under News in Brief
Tagged European Commission, IVDR, MDR

European Commission guidance on surgical masks

June 29, 2020
by Oliver Giesemann

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

Filed under COVID-19, News in Brief
Tagged COVID-19

European Commission’s device standardisation request rejected

June 23, 2020
by Michael Sander

The formal standardisation request from the European Commission to the European standards bodies will get essential standards work to support compliance with Regulation (EU) 2017/745 on medical devices (MDR). The… Read More

Filed under MDR, News in Brief
Tagged European Commission, MDR

Updated timetable for Eudamed

June 7, 2020
by Oliver Giesemann
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!

On its website on the European database on medical devices (EUDAMED), the European Commission has declared a new timetable for the new Eudamed medical device database. According to the Commission,… Read More

Filed under MDR, News in Brief
Tagged European Commission, IVDR, MDR, UDI

Clinical evaluation and equivalence – using literature under the MDR

June 5, 2020
by Michael Sander

Using literature for clinical evaluations was a common approach for setting up clinical evaluations under the MDD. This article discusses the new MDCG 2020-5 guidance document, which illustrates to what… Read More

Filed under Important Notice, MDR, News in Brief
Tagged Clinical Evaluation, Guidance Documents, MDCG, MDR

New MDR and IVDR guidance documents published by MDCG and MedTech Europe

June 1, 2020
by Michael Sander

mdi Europa is constantly screening various sources on news and guidance that could be of importance for medical device manufacturers. In this context, we came across two guidance documents that… Read More

Filed under IVDR, MDR, News in Brief
Tagged Guidance Documents, IVDR, MDCG, MDR

Medical Device Distribution in France

May 18, 2020
by Michael Sander

With 67 million inhabitants, France is the second largest market in Europe after Germany. And this also applies to the Medical Device sector. Therefore, medical device manufacturers from all over… Read More

Filed under Important Notice, News in Brief
Tagged News in Brief

Surgical and FFP masks in the COVID-19 crisis

May 8, 2020
by Oliver Giesemann

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

Filed under COVID-19, Important Notice, News in Brief
Tagged COVID-19, European Commission, Guidance Documents

Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published

April 29, 2020
by Michael Sander

The European Commission seemingly wants to catch up with the shortfalls of the last years. Late April, the following guidance documents for Regulation (EU) 2017/745 on medical devices (MDR) have… Read More

Filed under Important Notice, MDR, News in Brief
Tagged Clinical Evaluation, Guidance Documents, IVDR, MDCG, MDR

MDR Postponed by One Year!

April 28, 2020
by Michael Sander

What has been proposed by the European Commission and confirmed by the European Parliament has been signed off by the European Council.  As a consequence, the delay of Regulation (EU)… Read More

Filed under Important Notice, MDR
Tagged COVID-19, European Commission, MDR

European Commission gives details of how to prevent COVID-19 test failures

April 23, 2020
by Oliver Giesemann

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

Filed under COVID-19, Important Notice, News in Brief
Tagged COVID-19, European Commission, Guidance Documents, IVDD
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Important facts about mdi Europa

mdi Europa was founded in 2000 to provide high quality regulatory affairs services for medical devices and in vitro diagnostics worldwide.
Our customers are:

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Our high quality compliance solutions, as confirmed by our ISO 9001:2015 certification include:

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BfArM informs about damages to hip implants

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