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Manufacturers of Reusable Surgical Instruments: BSI Launches Urgent Appeal

Manufacturers of Reusable Surgical Instruments: BSI Launches Urgent Appeal : submission of applications regarding TF for 1R MD to be received within November 01, 2019

Dear Partners and Manufacturers of 1 R MD more particularly,

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Last late August 23rd, the British Standards Institution (BSI) issued an urgent appeal to manufacturers of class I reusable surgical instruments:

You certainly knew that, according to Directive 93/42 / EEC, these devices could be placed on the market without the intervention of a notified body.

But this changes with Regulation (EU) 2017/745 (RDM): to be able to continue to be marketed after 26 May 2010, they will have to have a EU certificate according to the RDM, issued by one of the (rare) bodies notified under this Regulation.___For the manufacturers concerned who had chosen / choose BSI as a notified body, the latter warns them that their applications must be received before 1 November 2019

, otherwise the EU certificates are unlikely to be delivered in time for the expiry of the deadline. May 26, 2020, which would stop the continued marketing of their surgical instruments.

BSI has probably warned you already, but just in case, as a mere memo...

As you see, this is is very serious and URGENT warning.

As ever,Our best regards,


MME team members

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