Apologies for the late input here, however I think it is valuable. There are several items to note in the current regulatory environment. I'll begin with Brexit. We currently have an extension through October 2019. The assumption that UK Notified Bodies will no longer exist post-Brexit is not entirely accurate. If a Brexit deal is negotiated such that mutual recognition is agreed upon, then UK Notified Bodies may have the same status as they have today. Ultimately, there are several scenarios that could take place and it is prudent for manufacturers and Notified Bodies to understand the risks associated with all contingencies and prepare accordingly. As noted, BSI has done so already.
With the current extension to Brexit, BSI is accepting MDR applications from its existing clients at this time through its designated UK office although as we all learn the new process together, the initial launch of the MDR system is limited so we can navigate these new waters carefully.
New applications under the MDD are quite limited as the timescale for application, review, assessment of technical documentation, recommendation, and certificate issuance is very short. I would highly recommend that any manufacturer work very closely with its notified body to build on its current MDD knowledge base to map a pathway to MDR that makes the most sense. There are pragmatic resolutions to any situation, we simply need to work together to define that path. As always, please feel free to reach out to me directly for any assistance I can provide.
Respectfully,
Bill Enos
Senior Commercial Operations Director
BSI Regulatory Services (Medical Devices) Americas
------------------------------
Bill Enos
Senior Commercial Operations Director
BSI Regulatory Services (Medical Devices
Americas
------------------------------
Original Message:
Sent: 10-Jul-2019 15:44
From: Jo Huang
Subject: Submitting to MDD versus MDR- Timelines and Sentiments
EU's New MDR will start being applied in May 2020. Technically you could submit an old MDD application before then thus benefiting from the less stringent old rules, and then upgrading once the MDR system is fully operational. However, this strategy is just delusional for at least two reasons:
1. UK-based NBs will no longer be recognized by the EU after Brexit so BSI, for example, urged manufacturers to submit MDD CE application no later than March this year as submitting an MDD CE-Marking application after March could be stalled in backlog and won't be granted the MDD CE cert in time to beat the MDR deadline. Some even said in retrospect they should have made the cutoff Jan 1.
2. On the bright side, BSI got a contingency plan that BSI- Netherlands achieves designation for MDR filings so that clients have a fallback. It is expected that at the earliest manufacturers can apply for CE-Marking under the new MDR is in Q3 this year. But again, given the bottleneck in NB's capacity and their lack of MDR reviewing experience all device manufacturers face a real challenge. Particularly, timing will be of utmost importance for all of us.Just to echo Richard, you should address all your concerns directly with your NB as the answers will be different depending on your NB's current capacity/status.
------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States
Original Message:
Sent: 09-Jul-2019 13:39
From: Anonymous Member
Subject: Submitting to MDD versus MDR- Timelines and Sentiments
This message was posted by a user wishing to remain anonymous
Hello all,
I am wondering what the timeline is to submit to MDD instead of MDR. I have a few questions on this point:
-Is there a date of which no more MDD conformity assessments will be allowed for new devices? Is it May 2024?
-Can notified bodies not certified under EU MDR but certified under MDD still perform conformity assessments and CE marking for devices under the MDD?
-Even if the NB are able to accept conformity assessments under MDD, are they still accepting them for new devices or have they elected to stop? For MDD certified NB? For MDR certified bodies?
-What are the sentiments regarding applying under the MDD and utilizing the grace period versus applying under the EU MDR and waiting in the backlog?
-Is there a way to request a conformity assessment date under EU MDR?