Amendment of MDR (EU) 2017/745|OJ L241/7 on 8th July 2021

On 8 July 2021 an amendment to the Regulation on Medical Devices MDR (EU) 2017/745 was published in the Official Journal of the European Union with some changes and corrections, including, misprints, typos and translation errors.

What are the most significant changes?

Of the amendments made the most significant are:

• On page 104, attachment I, Chapter III, point 23.2, letters (c) and (d) General safety and performance requirements, the word “legally”has been added to registered office, as shown in the table below.

instead of:	should be read as:
“ (c) the name, trade name or registered trade mark of the manufacturer and the address of its registered office;”	“ (c) the name, trade name or registered trade mark of the manufacturer and the address of its legally registered office;”
“ (d) if the manufacturer has its registered office outside the Union, the name of the authorised representative and the address of their legally registered office;”	“ (d) if the manufacturer has its legally registered office outside the Union, the name of the authorised representative and the address of their legally registered office;”

• At page 143, attachment VIII, Chapter III, point 5.4 (Rule 8), fourth indentClassification Rules the risk class has been changed: Implantable Medical Devices undergoing post-implantation modifications from Class IIb to Class III, as shown in the following table.

instead of:	should be read as:
“– are intended to undergo a chemical modification after introduction into the body, in which case they belong to Class IIb, except when placed in the teeth,”	“– are intended to undergo a chemical modification after introduction into the body, in which case they belong to Class III, except when placed in the teeth,”

 

For more information on these and the other changes imade to the MDR (EU) 2017/745 please follow the link to the EU document here. 

Mi3 can offer strategic regulatory consulting services to companies producing Medical Devices and In Vitro Diagnostic Devices for release on national and international markets to ensure compliance of your devices to the Medical Devices Regulation MDR (EU) 2017/745.

Contact us today to learn how we can help you.