Regulatory Updates

April 07, 2022

EU Regulatory Update | News on the EMA expert panel and more

As of the first of March, the coordination on the expert panel has shifted from the Joint Research Centre in Italy to the pharmaceutical agency EMA in Amsterdam.
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April 06, 2022

EU Regulatory Update | MDR extension – the hot debate

If one thing is debated in the Brussels MedTech corridor, it is the path forward out of the resource and time crunch to get all products certified under MDR and IVDR. 
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April 05, 2022

EU Regulatory Update | The Slovenian Institute of Quality and Metrology (SIQ) designated as an MDR Notified Body

The Slovenian Institute of Quality and Metrology (SIQ) was designated as a Notified Body under Regulation (EU) 2017/745 (MDR).
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März 31, 2022

EU Regulatory Update | Detailed and clear policy on Dutch Authority intervention MDR/IVDR

The document describes the policy on healthcare supervision, and explains how it moves away from the old thinking into the new era of MDR and IVDR. 
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März 31, 2022

EU Regulatory Update | What is the difference between the European Union and the Union, and why does it matter for IVDR?

When applying the requirements of the IVDR, manufacturers should ensure that they are applying these for products and services supplied to laboratories and patients in countries within the Union (EEA) and not just those that are part of the EU.
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März 31, 2022

EU Regulatory Update | New revision of MDCG 2019-9 guidance

A revised version of MDCG 2019-9 (Summary of safety and clinical performance - A guide for manufacturers and notified bodies) has been published and made available on the EU Commission website.
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März 31, 2022

EU Regulatory Update | Data protection concerns for AI & Machine learning devices

Enisa, the European Union Agency for Cybersecurity published a paper in March on deploying pseudonymisation techniques. In this paper, pseudonymisation techniques are discussed in order to protect personal data by hiding the individuals in a dataset.
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März 31, 2022

EU Regulatory Update | Regulatory guidance for 3D-printed medical devices

3D printing or additive manufacturing technology has revolutionized the medical device industry during the last few years. This technology enables the opportunity for patient-specific healthcare solutions. 
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Februar 28, 2022

EU Regulatory Update | Deutschland erkennt SQS-Zertifikate an

Vor einiger Zeit hat die EU-Kommission hat eine Information an Interessengruppen herausgegeben, in der sie mitteilt, dass das Mutual Recognition Agreement (MRA) zwischen der EU und der Schweiz ab dem 26. Mai 2021 von der EU nicht mehr anerkannt wird.
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Februar 28, 2022

EU Regulatory Update | MHRA consultation on proposals for legislative changes for clinical trials

MHRA, the national authority for medical devices and pharmaceutical products in the UK, has launched a consultation, regarding the proposals for legislative changes for UK clinical trials.
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Februar 24, 2022

EU Regulatory Update | Expert opinions for MDR published

Two new Clinical Evaluation Consultation Procedure (CECP) options have been issued by expert panels for medical devices.
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Februar 24, 2022

EU Regulatory Update | Team-NB capacity causes risk of shortage of medical devices and IVDs

In December 2021, Team-NB issues a position paper to address concerns that there will a potential risk of shortage of medical devices/IVDs for patients in Europe.
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Februar 24, 2022

EU Regulatory Update | EU AI ACT- ongoing developments

On the 17th of January 2022, the latest compromise text from the French Presidency on the AI Act has been published.
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Februar 24, 2022

EU Regulatory Update | Annex XVI Products: Draft Implementing Regulation for the Common Specifications Published

On 14 January 2022, the European Commission published a new draft Implementing Regulation laying down the Common Specifications for the groups of products without an intended medical purpose that are listed in Annex XVI.
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Februar 24, 2022

EU Regulatory Update | Regulation (EU) 2021/2226 came into effect on 4 January 2022, what does it mean for providing eIFU?

On 14 December 2021, the European Commission adopted Implementing Regulation (EU) 2021/2226 laying down the rules for the provision of electronic instructions for use for devices covered by Regulation (EU) 2017/745 (the "Medical Devices Regulation"- “MDR”).
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Februar 24, 2022

EU Regulatory Update | Update to MDCG 2021-21 Guidance on Performance Evaluation of SARS-CoV-2 IVDs

In case you missed it, the MDCG updated in February the 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices, originally issued in August 2021.
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Februar 24, 2022

EU Regulatory Update | EUDAMED Legacy devices infographic

To better understand the different identifiers for Legacy Device the European Commission created an EUDAMED Legacy Device Infographic.
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Januar 28, 2022

EU Regulatory Update | TÜV NORD and ITALCERT are designated under MDR

In the past few weeks two new Notified Bodies have received designation under MDR.
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Januar 20, 2022

EU Regulatory Update | MDCG 2021-28 Substantial modification of clinical investigation under MDR

The MDCG is providing another form regarding communication with Competent Authorities about clinical trials.
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Januar 20, 2022

EU Regulatory Update | Robotics in Healthcare

Recently, a Technical Report was published by the Joint Research Centre (JRC), the European Commission’s science and knowledge service.
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Januar 20, 2022

EU Regulatory Update | New Health Technology Assessment Regulation

The regulation (EU) 2021/2282) aims to make vital and innovative health technologies, including certain medical devices and medical equipment, to be more widely available.
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Januar 20, 2022

EU Regulatory Update | Policy Agenda Dutch Healthcare Inspectorate

The Dutch Healthcare Inspectorate (IGJ) has published their working plan for 2022.
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Januar 20, 2022

EU Regulatory Update | Guidance update from the UK Medicines and Healthcare products Regulatory Agency (MHRA)

Several new and updated guidance documents from the MHRA became available in December and early January.
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Januar 20, 2022

EU Regulatory Update | Update to MDCG 2020-16 Guidance on Classification of IVD Devices

The MDCG quietly updated the 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.
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Januar 20, 2022

EU Regulatory Update | Dutch guideline for high quality AI in healthcare is released

The Dutch ministry of Healthcare, Welfare and Sports published the first version of the ‘Guideline for high-quality diagnostic and prognostic application of AI in healthcare.
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Dezember 23, 2021

EU Regulatory Update | International Council for Harmonisation (ICH) reports progress on guidelines and harmonization activities

The ICH met virtually on 17 and 18 November. Following these meetings, a press release was published on 25 November which summarized the ICH’ progress on existing and new guidelines and harmonization activities.
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Dezember 23, 2021

EU Regulatory Update | Update on the EU AI ACT; what’s to know?

Last summer, the text for a proposal for an EU Artificial Intelligence Act was shared for consultation. From this text it became clear that medical devices and IVD’s that use artificial intelligence are considered high risk AI systems and will have to comply with the EU AI Act.
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Dezember 23, 2021

EU Regulatory Update | Borderlines with medical devices and other products in Great Britain – an update

The Medicines & Healthcare products Regulatory Agency (MHRA) in the UK has issued version 1.4 of the guidance document on “Borderlines with medical devices and other products in Great Britain”.
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Dezember 23, 2021

EU Regulatory Update | SGS Belgium designated under MDR

In November SGS Belgium received designation as a Notified Body under the MDR.
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Dezember 23, 2021

EU Regulatory Update | Implementing regulation on EUDAMED and electronic IFU

Two implementing acts have been published by the EU Commission in the past weeks.
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Dezember 23, 2021

EU Regulatory Update | New harmonized standards to be cited in OJEU for MDR and IVDR

The European Commission announced its intention to cite new harmonized standards in the Official Journal of the European Union (OJEU).
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Dezember 23, 2021

EU Regulatory Update | IVD Instruments Installed and Put into Service Prior to May 26, 2022

Recent amendments clarify when different classes of IVD devices must be brought into compliance for continued distribution, but what about IVD instruments already in use within the EU?
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Dezember 23, 2021

EU Regulatory Update | Virtual Reality (VR) has proven to be a promising technology to be used in several areas within the clinical domain.

It is expected that, by 2025, healthcare and medical devices industry will be one of the main industries in which VR is used.
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November 24, 2021

EU Regulatory Update | Medical Device Coordinating Group (MDCG) stipulates MDR legacy device surveillance requirements

The list of guidance documents of the Medical Device Coordinating Group (MDCG) steadily continues to grow and on 21 October a new guidance was released that discusses post-market requirements for legacy devices in the transitional period (under MDR Article 120.3).
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November 24, 2021

EU Regulatory Update | European Medicines Agency (EMA) publishes new guideline on registry-based studies

The new EMA guidance may provide useful scientific guidance to medical device manufacturers.
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November 24, 2021

EU Regulatory Update | Team-NB proposal for art. 117 Notified Body opinion template

Team-NB, the trade association of Notified Bodies, has published their proposed template for issuing opinions according to article 117 on the device part of combination products.
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November 24, 2021

EU Regulatory Update | Cybersecurity: what standards to use and what are examples of good cybersecurity practices?

Currently we see that there is a lot of misunderstanding of what cybersecurity actually entails.
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November 24, 2021

EU Regulatory Update | Comparison of the AI whitepapers from BSI, TÜV Süd and MHRA on AI

We see in the world that initiatives for regulation of artificial intelligence and machine learning is increasing with many regulations and guidance documents already published. Europe however is still laying behind.
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November 24, 2021

EU Regulatory Update | Updates to the Joint Implementation and Preparedness Plan for IVDR

In June 2021, the Member States and the Commission services released its initial Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
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November 24, 2021

EU Regulatory Update | MDCG 2021-26 Questions and Answers on repackaging & relabeling activities (EU) 2017/745 and (EU) 2017/746

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November 24, 2021

EU Regulatory Update | MDCG guidance plan updated

Approximately 5 months after the previous version, an updated plan for MDR/IVDR related MDCG guidance documents was published.
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November 15, 2021

Memo combination custom made and CE devices 

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Oktober 27, 2021

EU Regulatory Update | Upcoming EU AI regulation and the Team-NB position paper

This summer, the proposal for an EU regulation on artificial intelligence was published for consultation.
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Oktober 27, 2021

EU Regulatory Update | New software technologies and Notified Body expectations

It’s already some time ago that ‘MDCG 2019-16 Guidance on cybersecurity for medical devices’ was published.
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Oktober 27, 2021

EU Regulatory Update | Pharma clinical trial regulations coming into effect on 31 January 2022

The clinial trial EU Portal and database of the Clinical Trial Information System (CTIS) will meet the requirements.
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Oktober 27, 2021

EU Regulatory Update | MDCG 2021-24: Guidance on classification of medical devices

On October 4th, 2021, the MDCG published MDCG 2021-24: Guidance on classification of medical devices.
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Oktober 27, 2021

EU Regulatory Update | IVDR Extended Transition Proposed – but don’t take your foot off the gas!!!

The Commission has issued a proposal for extending the transitional arrangements for the IVDR.
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Oktober 27, 2021

EU Regulatory Update | New revision of MDCG 2019-6 guidance

The third revision of MDCG 2019-6 has been published and made available on the EU Commission website.
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Oktober 27, 2021

EU Regulatory Update | MDR rolling plan – Brief update

An updated rolling plan has been published by the EU Commission this month, replacing the previous version from April 2021.
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Oktober 27, 2021

EU Regulatory Update | EUDAMED devices and certificates modules

Two new modules of EUDAMED went live at the beginning of October: Devices and Certificates modules are now functioning.
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Oktober 06, 2021

Free Webinar PPT Download | EU Regulation proposal on Artificial Intelligence

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September 29, 2021

EU Regulatory Update | Dutch competent authority publishes uniform national fees

News from The Netherlands, where on 17 September 2021 new national rates for the assessment of research under the EU regulations for research with a medicinal product and clinical research with medical devices were published.
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September 29, 2021

EU Regulatory Update | New 2021 amendment for ISO 13485:2016

On the 9th of September 2021, the European standards bodies, CEN and CENELEC published a 2021 amendment, EN ISO 13485:2016+A11:2021
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September 29, 2021

EU Regulatory Update | MHRA consultation on future UK medical devices legislation

MHRA, the national authority for medical devices and pharmaceutical products in the UK, has launched a public consultation.
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September 29, 2021

EU Regulatory Update | TEAM-NB published a position paper on medical devices exempted from an implant card

The notified bodies organized in TEAM-NB published a position paper on medical devices exempted from an implant card per article 18.3 of the Medical Device Regulation (EU) 2017/745 (MDR).
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September 29, 2021

EU Regulatory Update | IVD performance evaluation live in EU expert panel

The IVD expert panel from the European Commission has started to accept submissions from notified bodies for the Performance Evaluation Consultation Procedure.
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September 29, 2021

EU Regulatory Update | EMA finalizes guidance for pharmaceuticals using medical devices

The EU MDR has modified the pharmaceutical legislation for those pharmaceuticals that include a medical device, in particular the requirements under Article 117.
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September 29, 2021

EU Regulatory Update | ZLG checklist on clinical evaluation resurfaced

A renewed interest exists in the checklist for the verification of clinical evaluations issued by the German Authority ZLG.
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September 29, 2021

EU Regulatory Update | Publication of ISO/TS 82304-2:2021 Health software - Health and wellness apps

Published this month, ISO 82304-2 provides a set of requirements for developers of health and wellness apps, intending to meet the needs of health care professionals, patients, care givers and the wider public.
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August 31, 2021

EU Regulatory Update | First harmonised standards on the EU IVDR

The set, published on July 20 2021, is just a first few to get the system started. 
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August 31, 2021

EU Regulatory Update | New core standard: ISO 15223-1:2021

After a long period of back and forth, the standard on labelling was revised and published.
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August 31, 2021

EU Regulatory Update | MDCG keeps on producing guidance docs

The MDCG keeps on publishing documents.
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August 31, 2021

EU Regulatory Update | IVDR state of the industry

Informa, supported by NSF, have published a readiness report of the industry towards the new IVDR. 
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August 31, 2021

EU Regulatory Update | 6th IVDR notified body designated!

Good news to balance the above, as another notified body is designated for the IVDR.
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August 31, 2021

EU Regulatory Update | Brexit: MHRA delivery plan 2021-2023

The MHRA published their action plan for the transition away from the European system into a stand-alone system for the UK.
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August 31, 2021

EU Regulatory Update | Brexit: UK approved body - update

The UK government updated the listing of UK approved bodies listed under the medical device regulations 2002
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August 31, 2021

EU Regulatory Update | Swixit: news on economic operators

The paper is helpful in several ways.
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Juli 31, 2021

EU Regulatory Update | Health Technology Assessment: Informal deal between Council and European Parliament

The European Council and the European Parliament made a political deal on a legislative proposal concerning joint work on health technology assessment.
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Juli 31, 2021

EU Regulatory Update | EMA update on the Q&A for combination products

EMA updated their 2019 Q&A document on the implementation of the MDR and IVDR ((EU) 2017/745 and (EU) 2017/746). 
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Juli 31, 2021

EU Regulatory Update | Clinical Expert panel CECP revokes first opinion directly following publication

Interesting developments with the clinical expert opinion of the European Commission. 
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Juli 31, 2021

EU Regulatory Update | New ISO standard on labelling ISO 15223-1:2021 published

The long await standard on labelling has been published: ISO 15223-1:2021
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Juli 31, 2021

EU Regulatory Update | Series of MDCG guidance documents published in pre-summer break spur

The MDCG has been busy ticking off many guidance documents from their active engagement list, getting everyone some nice summer break reads and study materials.
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Juli 31, 2021

EU Regulatory Update | First list of harmonised standards published

The European Commission publishes the first references of harmonised standards for the EU Regulations on medical devices to confer presumption of conformity in the OJEU.
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Juli 31, 2021

EU Regulatory Update | EU Market Surveillance and Compliance Regulation EU/2019/1020 now applicable

The EU Market Surveillance and Compliance Regulation EU/2019/1020 has become fully applicable. 
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Juli 31, 2021

EU Regulatory Update | Additional MDR notified body designated

Kiwa Cermet has appeared on NANDO as the third Italian Notified Body under MDR and 22nd to be designated in total (only 21 remaining active after Brexit).
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Juni 30, 2021

EU Regulatory Update | MRA news: Turkey, Switzerland, Australia

Agreements on Turkey, Switzerland and Australia
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Juni 30, 2021

EU Regulatory Update | Joint Action plan Market Surveillance

The Joint Action on Market Surveillance of medical devices (JAMS) was set up to reinforce market surveillance between Competent Authorities and to harmonise the approach taken across all Member States.
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Juni 30, 2021

EU Regulatory Update | Joint Implementation plan IVDR

The European Commission has published a joint implementation plan regarding the IVDR.
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Juni 30, 2021

EU Regulatory Update | Draft implementing act EUDAMED

A draft Commission Implementing Regulation on EUDAMED use under the EU MDR has been published for comment.
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Juni 30, 2021

EU Regulatory Update | EMDN update

The European Commission has published a Q&A document on the EMDN referred to in the above update ion EUDAMED.
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Juni 30, 2021

EU Regulatory Update | MDCG guidance development

The latest publications from Brussels include the following:
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Juni 30, 2021

EU Regulatory Update | Fulfillment Service Providers

In case you are a fulfilment service provider per EU 2019/1020, on in case you are using one or more as supplier, please note the date of application is nearing: July 16 2021.
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Juni 30, 2021

EU Regulatory Update | MHRA update on clinical studies in UK

Brief update for those performing clinical studies in UK or considering doing so.
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Juni 30, 2021

EU Regulatory Update | TEAM-NB / NBCG-med remote audit survey

The joint notified bodies used a commission services tool to run a survey on all notified bodies in regard to their experiences with remote audits.
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Juni 29, 2021

EU Regulatory Update | Update NB designations

No news in MDR land; one additional NB in IVDR world: Dekra Netherlands.
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Mai 31, 2021

EU Regulatory Update | Series of EU guidances

The European Commission workgroup MDCG has been quite busy updating guidances.
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Mai 31, 2021

EU Regulatory Update | EU proposal on regulating Artificial Intelligence

The long-awaited EU proposal for regulating AI is live and open for comment.
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Mai 31, 2021

EU Regulatory Update | Harmonisation of standards

Several standards have been included in the latest Harmonised Standards list, including EN ISO 11607-1:2020, EN ISO 14155:2020, or EN ISO 11607-2:2020. 
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Mai 31, 2021

EU Regulatory Update | Core-MD

New initiatives are coming to light
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Mai 31, 2021

EU Regulatory Update | Factsheet class I medical devices

A bit late in the game, but a publication of interest if you have class I medical devices that will remain class I under MDR.
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Mai 31, 2021

EU Regulatory Update | An agencies perspective on MDR state

As we are just past the MDR date of application, it would be of interest to read what the authorities have to say on this.
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Mai 31, 2021

EU Regulatory Update | EMDN – the new nomenclature

The European Union is updating the new EMDN, the nomenclature that will be used in EUDAMED and on CE certificates to identify types of devices.
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Mai 31, 2021

EU Regulatory Update | E-labeling in Europe

Another draft piece of legislation handles with the electronic labeling. 
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Mai 31, 2021

EU Regulatory Update | UDI helpdesk

A helpdesk has been set up to guide you through the maze of UDI requirements and guidance.
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April 29, 2021

EU Regulatory Update | MDR rolling plan – Brief update

An updated rolling plan has been published by the EU Commission this month, replacing the previous version from December 2020. It can be found here: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_rolling-plan_en.pdf

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April 29, 2021

EU Regulatory Update | Notified Body designations

This month another designation was finished. Eurofins (Finland) has appeared on NANDO as the second Finnish Notified Body and 21st to be designated in total (only 20 remaining active after Brexit).
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April 29, 2021

EU Regulatory Update | New standardization request - guidance on standardisation – new harmonised standards

Standardisation request
A new attempt is in place, trying to get standards harmonized. Details can be found at: https://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.detail&id=599#
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April 29, 2021

EU Regulatory Update | Notified Body Scream…

Let's stare into the abyss with the newest Notified Body survey published by Team-NB: https://www.team-nb.org/wp-content/uploads/2021/04/Team-NB-MD-Sector-Survey-PressRelease-20210414.pdf
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April 29, 2021

EU Regulatory Update | Initial conformity assessment process: difference MDR from MDD – a notified body view

Reference: Klaus-Dieter Ziel, MEDCERT GmbH, April 20 2021

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April 29, 2021

EU Regulatory Update | IFU

A long-awaited new standard is out! ISO 20417:2021 Information to be supplied by the manufacturer): https://www.iso.org/standard/67943.html

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April 29, 2021

EU Regulatory Update | Biological evaluation of absorbable medical devices

Some good news on the biological evaluation of absorbable medical devices.
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April 29, 2021

EU Regulatory Update | MDR – final confusion on transition: art 120.3 vs art 123

A topic that briefly surfaced at the time of publication of the MDR is coming back, just days before the Date of Application. 
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Mai 15, 2020

Medical device GSPR comparison between China and the EU

To build a scientific medical device supervision system and speed up the integration with the international community, China NMPA organized relevant departments to translate the IMDRF "Essential Principles of Safety and Performance" version 2018, and a notice (No. 18 of 2020) about this "Essential Principles" was formally released.
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Mai 01, 2020

Wegleitung benennung eines Bevollmächtigten für Medizinprodukte von Schweizer herstellern 

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April 27, 2020

Exclusive Download: All Questions Answered - Q&A Preparing for MDR in times of remote working

On the 25th of March 2020, Bassil Akra (VP Global Focus Team TÜV SÜD), Gert Bos and Erik Vollebregt (Partner at Axon Lawyers) shared their insights during the webinar: Effective use of downtime – preparing for MDR in times of remote working. The webinar also included a Q&A were all attendees could ask their question to our experts. Download the document for all the answers to your questions, given by our experts!
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März 17, 2020

New Borderline Manual of Cosmetic products version 5.1 available

The new Borderline Manual of Cosmetic products (subgroup on borderline products) version 5.1 is now available. Are you in doubt if your product falls under cosmetic or Medical Device Regulation? Are you looking for a right classification? We can help you decide based on mode of action and indications of your product.
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März 05, 2020

IVDR Webinar Survey Results

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Dezember 08, 2017

EU Releases Long-Awaited Designation Codes for Notified Bodies

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Dezember 04, 2017

New version of the borderline manual

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Mai 05, 2017

Official Journal of the European Union

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Mai 02, 2017

China CFDA annual report on Medical Device Registration 2016

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