Changes	Former law until May 26th, 2017 (EU) No 722/2012	Law from May 26th, 2020 (EU) 2017/745 – 2017/746
Authorities: Notified bodies	“Industry partners” roles	“Policing bodies” roles: - Unannounced audits - Maintaining their notification - Special notified bodies: for high-risk medical devices
		Implementation of expert committees
Manufacturers	Definition: - Handles only manufactured products	Definition: - Handles also fully refurbished products
	Responsibilities: - Maintain a Technical File - Quality management system	Characteristics: - Qualified Person - Specific Annex II for technical documentation - Process of clinical evaluation - Market surveillance - Involvement of authorities and/or expert groups in the market approval - Common standards
		Responsibilities: - Maintain a Technical File - Quality management system (including continuous product improvement)
		Obligations: - Technical file - Declaration of conformity - UDI system; Registration - Labeling
Technical file maintenance		New points: - Filed since the last device was placed on the market for at least 10 years (all devices), 15 years (implantables) - If the manufacturer is outside the EU, this is a responsibility of the EU REP
Transparency		Creation of European Union Global Database (EUDAMED)
Devices with a non-medical purpose	Not included	- “Cosmetic” contact lenses and other devices intended to be inserted in the eye - Cosmetic surgery fillers (excluding tattoo ink) - Equipment for liposuction - Light emitting equipment for cosmetic use (tattoo or hair removal) - Brain stimulators - List may be integrated over time (Article 1.c)
New definition of medical device	Includes medical devices of control of conception	- Eliminates medical devices of control of conception - Includes medical devices for providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations
Falsified device	Not included	False presentation of identity, source, … - False documentation for CE mark - Does not include un-intentional NCs
User related definitions	Not included	User: healthcare professional or lay person that uses the device - Lay person: person with no formal education in the field of use of the device
Quality management system (QMS)		Improved contents: Plans, procedures, surveillance, communication and improvements
Classification rules	18 rules in total	- 23 rules in total - Risk assessment of the intended time of use
Classification path	- Invasiveness - Special rules - Additional rules	- Device identification - Length of use - Invasiveness - Source of energy - Special rules