Medical Device Regulation
The medical device directive (MDD) has been in force since 1996 and it is mandatory to comply with it to CE mark products in the EU. There has been an amendment in 2007 (2007/47/EC) and today there is a new regulations on its way to replace the directive, MDR. The new regulations are based on the MDD, the guidance documents to the MDD (MEDDEV), worldwide guidance and also some new and changed parts are being introduced. This introduction course will give an understanding of the expectations what is coming although not yet fully in force. The new guidance documents will be covered as well.
About Medical Device Regulation
Goal:
To give a good introduction of the MDR as preparation of what is coming soon.
Who benefits:
Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support and marketing, distributors, importers and authorized representatives as applicable.
Course Leader:
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.
Language:
Course material is in English.
Presentation in English or Swedish (depending on the participants).
Program:
The course is for two days with a written examination. Chapters VIII-X are briefly covered in parallell.
Day 1:
Introduction MDR
Chapters I – IV with relevant appendices and guidance along, exercises and workshops within definition, technical documentation.
Day 2:
Chapters V -VII with relevant appendices and guidance along, exercises and workshops within classification, labelling and PMS.
Examination
Venue:
The training is held in the area of Copenhagen, Denmark
About Medical Device Regulation
Goal:
To give a good introduction of the MDR as preparation of what is coming soon.
Who benefits:
Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support and marketing, distributors, importers and authorized representatives as applicable.
Course Leader:
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.
Language:
Course material is in English.
Presentation in English or Swedish (depending on the participants).
Program:
The course is for two days with a written examination. Chapters VIII-X are briefly covered in parallell.
Day 1:
Introduction MDR
Chapters I – IV with relevant appendices and guidance along, exercises and workshops within definition, technical documentation.
Day 2:
Chapters V -VII with relevant appendices and guidance along, exercises and workshops within classification, labelling and PMS.
Examination
Venue:
The training is held in the area of Copenhagen, Denmark