Re: Class I device will be IIa after new MDD
Hi Phil,
Still time left before the formal publication. And then Notified Bodies will have to be renotified, possibly through another joint audit of competent authorities. And then you NB will have to review and certify.
Best course for action:
1. Download the proposal text of the MDR, to be discussed tomorrow.
2. Look into Annex II on the technical file requirements
3. Update your files to these requriements.
4. Then, look into the QMS requirmeents as identified in Article 8 and related Annex VIII.
5. Upgrade your QMS.
6. Talk already with your current NB on including those products in their schedule 2018-2019.