There are several devices that are available on the market that do not require a CE certificate from a Notified Body under the current Medical Device Directive (MDD). Some of these, however, will require Notified Body certification under the Medical Device Regulation (MDR) by the 26 May 2020 date of application.
Class I reusable surgical instruments fall into this category.
‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused.
You must obtain an MDR CE certificate under Annex IX Chapters I and III or Annex XI – Part A (limited to re-use aspects) for these devices by the 26 May 2020 to ensure continued market access.
If you have any Class I reusable surgical instruments within your product portfolio, we would like to know how many products need to meet the deadline and recommend that you submit your application for conformity assessment to BSI immediately.
To help us to ensure you have continued market access for your products, your submissions need to be with BSI by 1 November 2019 at the very latest. All applications are processed on a first-come-first-served basis and applications received by BSI after 1 November 2019 may be at risk of not achieving certification by 26 May 2020.
What should you do now?
Please complete our device schedule form and send to Meddev.Enquiries@bsigroup.com to let us know which Class I reusable surgical instruments you need certification for immediately.
Please contact your Commercial Account Manager or Scheme Manager if you have any questions.