News

Actors can now register to Swissdamed!

Effective today, August 6, 2024, the ‘’Actors’’ module of the Swissdamed medical devices database is active! Manufacturers, importers, authorised representatives can now register through the…

MDR FSC: CAMD Q&A

The Competent Authorities for Medical Devices (CAMD) network issued on June 2022 a document on Questions and Answers regarding Free Sales Certificates (FSC) and Article…

IVDR: New harmonised standards

The Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products,…

MDR: New harmonised standards

The Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices,…

UDI Helpdesk ready for use!

The European Commission has launched the UDI (Unique Device Identification) Helpdesk to provide assistance in implementing the UDI-related requirements of the MDR and IVDR and…

EMDN is online!

The European Commission has released and opened for consultation the first (English) version of the European Medical Device Nomenclature (EMDN). This is an important step…

EUDAMED: State-of-play

Despite projections that it will be possible to perform device and Certificate registration directly to EUDAMED from May 2021 – aligning with the MDR date…

COVID-19 & NB audits: MDCG Q&A

The MDCG issued a Questions & Answers (Q&A) document concerning the previously issued Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19…

What is a Regulatory Strategy?

‘’Regulatory strategy’’ or ‘’strategy for regulatory compliance’’ is a new concept in the EU regulatory framework on medical devices introduced by the upcoming Regulation (EU)…

MDR:17th NB Designation

Since this morning, the NANDO database is richer for a new certification body. The Notified Body 3EC International a.s. is the 17th Notified Body notified…

Highlights of the week (CEAR)

Clinical evaluation assessment report template released by the MDCG Clinical evaluation assessment report (CEAR) will document the conclusions of the Notified Body assessment of the…

New MDR NB designation

The French Notified Body GMED is newly listed on the NANDO website, and is the 15th Notified Body accredited under the Regulation (EU) 2017/745 on…

Highlights of the week

We are happy to announce our collaboration with Team-PRRC, who recently joined Our Network. Our Library of documents was updated with: Guidance on regulatory requirements…

New NB under the MDR!

This morning, a Swedish notified body joined the NANDO database of certification bodies accredited under the MDR. Intertek Medical Notified Body AB Torshamnsgatan 43, Box…

MDR: Consolidated text

We are happy to share with you that the consolidated version of the MDR – Regulation (EU) 2017/745 was published on EUR-lex. The new text…

MDR: New NB designation

The European Commission announced the 11th Notified Body designated under the Regulation (EU) 2017/745: National Standards Authority of Ireland (NSAI) 1 Swift Square, Northwood, Santry…

Risk Management

  In view of the recently published ISO 14791:2019, our experts updated the already published MDlaw guidance document/template to assist you drawing a detailed Risk…

IVDR: 3rd NB accredited

Today, the European Commission updated the NANDO database by adding another Notified Body accredited for the assessment of devices under the In Vitro Diagnostic Medical…

8th NB designated under MDR

NANDO database is richer for another Notified Body accreditation under the Medical Device Regulation – (EU) 2017/745. Dutch Notified Body DEKRA is the 8th NB…

EUDAMED delayed!

The European Commission officially announced the delay of the EUDAMED database to May 2022: ” The Commission concluded that it will only be possible to…