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Revision of MEDDEV 2 12-1 rev. 8 Vigilance System in Europe
In January 2013 new Revision 8 of MEDDEV 2.12-1 about vigilance system in Europe was posted on the European commission webpage. The document itself can be found here. We’ll highlight below the changes...
View ArticleLabelling for Medical Devices in Europe: finally no change
Manufacturers of medical devices in Europe won’t need to change their labeling. Initially EN 980:2008 was about to be replaced by EN ISO 15223-1:2012 but as stated by the European Commission that won’t...
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Revision of MEDDEV 2 12-1 rev. 8 Vigilance System in Europe
In January 2013 new Revision 8 of MEDDEV 2.12-1 about vigilance system in Europe was posted on the European commission webpage. The document itself can be found here. We’ll highlight below the changes...
View ArticleClik here to view.
Labelling for Medical Devices in Europe: finally no change
Manufacturers of medical devices in Europe won’t need to change their labeling. Initially EN 980:2008 was about to be replaced by EN ISO 15223-1:2012 but as stated by the European Commission that won’t...
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Updated Harmonized standards MDD in Europe
May 16, 2014: the list of harmonized standards for the medical devices directive is updated. It’s been more than one year since this list was updated. Last time was Jan. 24, 2014. So what’s the change...
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FAQ Notified Body Unannounced Audits
Having visitors is not always a pleasure. On top of that some of them have the right to step in. So it’s better to be prepared for that situation and deal with it no matter what happens. How do you...
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borderline and classification medical devices
borderline and classification medical devices: UPDATED MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.16 (07-2014) Borderline cases are...
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NBOG Publishes revised Notified Body guidance documents
The Notified Bodies Oversight Group (NBOG) has published (Nov. 2014) the following revised Notified Body guidance documents. The aim of such guidance is to address some of the best practice expected...
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Medical Device Regulation date of application postponed to 26 May 2021
Medical Device Regulation date of application postponed The European medical device regulation 2017/745 have been postponed one year later in order to avoid shortages in getting key products available...
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EU MDR
EU MDR – Guide overview Below is a summary of different activities pertaining to the EU MDR (Europe Medical Device Regulation 2017/745). Compliance with EU MDR requirements will be mandatory starting...
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Medical Device Classification in the EU MDR
Medical Device Classification in the EU MDR One of the first concerns for manufacturers of medical devices attempting to sell their products on the European market is to decide what class is suitable...
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EU MDR standards
EU MDR standards The manufacturer must justify and document the design steps of his device. He must verify compliance with the requirements of Annex I to the European Medical Device Regulation 2017/745...
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EU MDR risk management
EU MDR risk management EU MDR risk management requirements can be implemented with the help of the harmonized standard EN ISO 14971. The manufacturer must ensure risk management activities are carried...
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EU MDR clinical evaluation
EU MDR clinical evaluation EU MDR clinical evaluation requirements are quite overwhelming. There are a lot of requirements and the strategy to achieve conformity is not always clear. We cover those...
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EU MDR UDI
Definition of UDI from the MDR EU MDR UDI has been introduced and even though it may not be new for those selling medical devices in USA, it is a new requirement to achieve the CE marking of a medical...
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EU MDR Technical Documentation
EU MDR Technical Documentation Summary The European Medical Device Regulation 2017/745 requires the compilation of technical documentation. See below a summary of the information to be included to...
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EU MDR Post-market surveillance
EU MDR Post-market Surveillance System The European Medical Device Regulation 2017/745 requires establishing a post-market surveillance system once the medical device is on the market. The EU MDR...
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IVDR
What is the IVDR? There has actually been an EU Directive (98/79/EC) controlling in vitro diagnostic medical devices (IVDs). Nonetheless, troubles emerged with the analysis and also application of...
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EU MDR
What is the new EU MDR? Everything you need to know The European Union (EU) Medical Device Regulation is the latest step in regulating medical devices in the European Union and has been developed to...
View ArticleEU MDR harmonized standards
EU MDR harmonized standards first set released The manufacturer must justify and document the design steps of his device. He must verify compliance with the requirements of Annex I to the European...
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