Checklist MDR GSPR

The long-awaited checklist for the MDR compliance is available to all MDSS clients. Please contact us via email clemos@mdss.com to order it.  

– MDSS clients: € 390
– Not MDSS client: € 590

The checklist is a great tool for the transition to the MDR with your current MDD compliant products. Are you not tired of the Notified Body answer: “What you have done for the MDD essential requirements (ER) will not be sufficient. There is definitely more for you to do with the MDR GSPR."

The checklist will provide an immediate status of the compliance evidence for the MDR GSPR with utilizing the MDD ER information. We expect that for the majority of products - in particular, the lower risk class products compliance may already be quite well established with the current information available for the MDD ER. However, as long as you cannot prove this you may lose it.

The exact differences are laid out therefore; even subtle variances will be caught. Should the current information not be sufficient, this tool will support you to identify and provide the chance to address them quickly. The sooner those gaps are identified, the better.

Once each gap is closed, you will establish full compliance.

This tool is also tremendously important to make use of the “soft transition” with your MDD certificate. This document as well provides for the MDD compliance. It fully supports the MDD certificate for the time being.  Meaning you will not be forced to maintain two set of documents. And certainly make it part of your QM System (see article 10 9. (b).

Once all gaps are addressed, then your product compliance is established and you are ready to tackle other MDR aspects with the confidence that your product is safe and performs as intended


Indeed, this should be first on the manufacturer MDR list to address! 


Speaking at the RMD in New Jersey

Dipl.- Ing. Ludger Möller will be speaking at the next RMD 2019 event which arrives to the USA for the first time.


MDSS Roadshow

Important: Agenda will include latest discussions on the MDR implementation development and certainly latest Brexit news will be covered!

The workshops will be hosted by Dipl.-Ing. Ludger Möller, a veteran expert on European Medical Device and IVD Regulations. Notified Bodies and other consultants will be invited to share their knowledge.

MDR

  1. Egypt - September 2019. Details will follow...
  2. TBA: Central USA – Denver. Details will follow...
  3. Southern California – Anaheim (after the MD&M) – Friday, 14th February, 2020 – near airport – Notified Body participation. Details will follow…

IVDR

  1. Anaheim – Friday, August 9, 2019Venue: New Horizons, 1900 S. State College Blvd., Suite 100, Anaheim, CA  92806, USA. Register here!

Contact us for our In-house workshop tailored to meet your requirements! Check out the calendar on our website for the availability of Dipl.-Ing. Ludger Möller being close to your location for special discounts. 


April, 2019 update

  • The Brexitxitxit ExExExtension – The never-ending Brexit story!

  • Basic GMDN membership for free

  • MDSS Roadshow

read more...


April, 2019 

  • CND code
  • MDSS Roadshow

read more...


March, 2019 

  • Brexit: MDSS UK Subsidiary
  • MDSS Roadshow

read more...


February, 2019 - Second Update

  • MDSS Roadshow
  • Brexit: Q&A issued by the Commission on the UK leaving the EU without a deal

read more...


February, 2019 - Update

  • MDSS Roadshow
  • Vigilance Guidance update

read more...


February, 2019

  • Constant updates and where to get the right news
  • MDSS Workshops
  • National Registration updates

read more...


January, 2019 - Second update 

  • Meet MDSS

  • Draft law for Brexit

  • First Notified Body

read more...


January, 2019 - Update


  • MDR

  • Brexit

read more...


January, 2019

  • International MDR Happening & upcoming events

  • Brexit

  • MDR/IVDR EU Commission website

read more...


November, 2018

  • International MDR Happening
  • Latest Brexit News

read more...