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Position paper Medical Device Lifetime

The Team-NB Position Paper defines the lifetime of medical devices under the Medical Devices Regulation 2017/745. It addresses the lack of a specific definition…

Extension of the MDR transitional period

New EU Regulation 2023/607 came into force on March 20, 2023, regarding the extension of the transition period for the MDR.

Extension of the Medical Devices Regulation (MDR) transition

The European Parliament has voted to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving products in the…

Submitting Technical Documentation under the MDR?

Submitting Technical Documentation? Read the Team-NB Position Paper on Best Practice Guidance for the Submission of Technical Documentation under Annex…

Notified body capacity

The MDCG recognizes that significant and urgent challenges remain in ensuring sufficient capacity of notified bodies and readiness of manufacturers in…

Manufacturers approach to the MDR bottleneck around May 2024

MDCG 2022-11: a position paper of the MDCG about how manufacturers of medical devices may approach the MDR certification bottleneck in May 2024

MDCG 2022-05 Guideline on borderline products

This guidance covers all products on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.

The importance of the device label to a global UDI system

The importance of the device label to a global UDI system

MDCG 2021-26 Q&A on repackaging & relabelling activities

MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

New MDCG guidance document MDCG 2021-24

TUV Rheinland Italia designated Notified Body MDR

TUV Rheinland Italia designated Notified Body MDR

Technical Boards of CEN and CENELEC accepted standardization request

Technical Boards of CEN and CENELEC accepted standardization requests.

Update references of harmonised standards for medical devices

The references of harmonised standards for medical devices under directives has been updated by the European Commission.

MDCG 2021-3 Questions and Answers on Custom-Made Devices (MDR)

MDCG 2021-3 Questions and Answers on Custom-Made Devices (MDR).

Remote Notified Body Audits possible for MDR and IVDR

Remote Notified Body Audits possible for MDR and IVDR.

Eudamed launched with actor registration module live

The EC’s Eudamed database launched on Tuesday December 1 with the actor registration module available to member states and economic operators.

MDCG 2020-13 clinical evaluation assessment report

MDCG 2020-13 clinical evaluation assessment report, a core requirement of the Medical Device Regulation (EU) 2017/745 (MDR).

ISO/TR 24971:2020 Guidance on the application of ISO 14971

ISO/TR 24971:2020 ISO/TR 24971:2020 Guidance on the application of ISO 14971.

MDR Date of Application 26 May 2021

Last friday, April 17th, the proposal by the EU commission to postpone MDR 12 months was finally accepted by the EU parliament with 693 in favor, 1 against,…

Update harmonized standards for MDD & IVD directives

The European Commission publishes an update of harmonized standards for Medical Devices & IVD directives.

Will MDR be postponed for a year?

MDR would apply from May 26. Due to the impact of COVID-19 on national authorities and the medical device industry, the European Commission is asking for…

MDCG Offers MDR Implementation Plan, ‘Significant Change’ Guidance

MDCG released guidance to provide clarification on the changes to devices under MDR Article 120(3).

NSAI 11th Notified Body MDR

"Worst case scenario" MDR and MDD realistic for third countries?

Third country compliance for Swiss manufacturers for all products under MDR and MDD from 26 May 2020 is currently the realistic «worst-case scenario».

MDCG 2019-15 Guidance Notes Class I Medical Devices

These guidance notes do not aim to be a definitive interpretation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April…

DEKRA Certification B.V. designated under MDR

DEKRA Certification B.V. is the 3rd Dutch notified body designated under the EU MDR

MDCG 2019-11 Software classification in the MDR and IVDR

Last month the European Commission released MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation MDR and IVDR.

TÜV Rheinland 5th Notified Body MDR

TÜV Rheinland 5th designated Notified Body under EU-MDR.

US asked to push back the deadline for the new EU MDR requirements.

The United States has asked the European Union to push back the compliance deadline for the new EU MDR requirements by three years.

DEKRA Germany 3rd NoBO under MDR

DEKRA Germany is the 3rd NotifiedBody to receive designation against the EUMDR as listed on the Nando website.

LRQA dropping out as Notified Body

Notified Body capacity is rapidly decreasing. Notified Body LRQA is dropping out of the Notified Body pool for medical devices and IVDs.

Virtual Manufacturing of Medical Devices

The MHRA has published a new guidance with regard to "Virtual manufacturing of medical devices".

FAQ transition timelines MDR/IVDR

The Transition Sub Group (TSG) of the CAMD today presented the outcome of their discussions regarding transition-related provisions regarding the MDR (i.e.…

MDR/IVDR roadmap published

The CAMD network is delighted to be able to publish the high-level Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap.

Human Factors and Usability Engineering

Read the guidance from the MHRA on 'Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products

Interactive guidance MHRA

Interactive guidance from MHRA published in EU-MDR and IVDR.

MDR / IVDR approved

Medical devices: more safety, more traceability. That is how the EU reported today’s approval ...

EU MDR / IVDR publication close

EU MDR and IVDR are getting close. Publication expected May 5, 2017. Get informed and take action...

Final text MDR /IVDR for voting

On 22 February 2017, the final text of the MDR and IVDR were published for voting on March 7, 2017.