Informational From RAPS – UK NB Will Not Apply for EU MDR/IVDR

Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
Any idea if there's been any contingency planning? There's currently only 2 NBs designated. I saw in another article you posted that 10 more are in the 'final stages' of designation. That's clearly WAY SHORT of what's needed.
 

pkost

Trusted Information Resource
#4
I'm conflicted by this.

the viability of this is a serious concern - if more notified bodies don't step up then the system will fail, however it indicates to me that things have been a bit too lax in the past and the regulation/supervision of products needs to step up

Where should this be positioned? Should we increase oversight and regulation with the goal to improve product safety and efficacy at the cost of avaliability of products on the market?

I don't think the MDR is too much, but perhaps it is too fast?
 

Ronen E

Problem Solver
Moderator
#6
I don't think the MDR is too much, but perhaps it is too fast?
1. Yes.
2. When the MDR was initially created and approved too many things were left "to be done later". Estimates were optimistic rather than realistic.
3. Almost everyone (manufacturers, EU authorities, NBs etc.) were sleeping in the sun for at least a year after the MDR came into force (May 2017) while they should have been busy bees drom day 1.
 

QM_123

Involved In Discussions
#7
As I know currently there are more than 50 NBs designated for MDD. After 11 months MDR will enter into force but now there are only 2 NBs designated for MDR. How many NB will be desginated until May 2020, do you have foresight or prediction on this matter?
 

Rincewind

Involved In Discussions
#8
As I know currently there are more than 50 NBs designated for MDD. After 11 months MDR will enter into force but now there are only 2 NBs designated for MDR. How many NB will be desginated until May 2020, do you have foresight or prediction on this matter?
I have read they expect somewhere between 12 and 20 notified bodies for MDR by the end of the year.
MedTech Europe letter is suggesting 12 NBs.

https://www.medtecheurope.org/wp-co...n_MDR-implementation-status_15-April-2019.pdf
 

Attachments

pkost

Trusted Information Resource
#9
3. Almost everyone (manufacturers, EU authorities, NBs etc.) were sleeping in the sun for at least a year after the MDR came into force (Mat 2017) while they should have been busy bees drom day 1.
I don't disagree that everyone was slow to start, however I have said from when I read the initial proposal that I wasn't sure where all of the expertise was going to come from - NBs need more experts, manufacturers need experts, EC-reps need experts etc etc...We already have a situation where there are not enough technical experts to support the notified bodies under the MDD, this isn't going to disappear with the additional burden from MDR. It is not quick and easy to train people up to the level that is required
 

Marcelo

Inactive Registered Visitor
#10
I just created another news, which will be published here in a while, it's a report from the EU Council, and, as always the report from the commissioner is that everything is working as planned.

I understand the concerns, but my view is that everything that is happening was already taken into account (you can read, for example, the 200+ pages of the REPORT ON THE IMPACT ASSESSMENT ON THE REVISION OF THE REGULATORY FRAMEWORK FOR MEDICAL DEVICES from 2012 and see that most of the things being discussed today were already noted) and thus, although some things need to be checked and revised, in general things are going ok.

In fact, my experience shows that the parts that are really not prepared are the manufacturers because they still do not understand the concept and scope of the new MdR (despite Medtech Europe saying that the manufacturer are "prepared").
 
Last edited:
Thread starter Similar threads Forum Replies Date
M RAPS RAC Device - Looking for resources / prep materials & study group Professional Certifications and Degrees 7
cscalise RAPS/Med Dev EU MDR Guidebook - Reviews or Opinions? EU Medical Device Regulations 5
M Informational From RAPS – Danish Medicines Agency Ramps Up Capacity in Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – 27% Will be Compliant? Survey Highlights Lack of Readiness for EU MDR Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – Novartis Inhaler is First Device to be Certified Under MDR Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – Operating System Vulnerabilities in Many Medical Devices, Germany’s BfArM and Device Firms Warn Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS: Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – Prep for Brexit: UK Seeks £25M Freight Service to Deliver Medicines, Devices Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay Medical Device and FDA Regulations and Standards News 3
M Informational From RAPS – Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’ Medical Device and FDA Regulations and Standards News 2
I Should I get IRCA ISO 13485 certification or RAPS certification? Career and Occupation Discussions 3
K RAPS RAC - Resources to prep for the RAC exam that don't cost an arm and a leg Professional Certifications and Degrees 4
S RAPS Regulatory Affairs Certificate Program Training - Internal, External, Online and Distance Learning 1
G RAPS RAC - Regulatory Affairs Certification Help Professional Certifications and Degrees 3
S Mathematics for Regulatory Professionals - RAPS Focus Article Other Medical Device Regulations World-Wide 0
R RAPS Certification Exam Prep Study Group for Spring 2014 Professional Certifications and Degrees 2
S 1st AHWP-RAPS Joint Conference @ KL, Malaysia 2-3 Dec 2013 Other Medical Device Regulations World-Wide 2
S RAPS Article on STED (Summary Technical Documents) Other Medical Device Regulations World-Wide 1
L RAPS RAC EU Certificate: is anyone going to put hands on? Professional Certifications and Degrees 4
Hershal Just for fun raps Coffee Break and Water Cooler Discussions 0
S FDA Enforcements for 2011 - RAPS article on FDA Inspections and Enforcements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L RAPS (Regulatory Affairs Professionals Society) books - Are they worth it? Professional Certifications and Degrees 8
S RAC (Regulatory Affairs Certification) from RAPS vs. a University Professional Certifications and Degrees 4
R RAPS Certification Relevant to IT Business Analyst? Professional Certifications and Degrees 4
F What is the duration of the RAPS RAC (EU) Exam? Professional Certifications and Degrees 11
M RAPS RAC - Regulatory Affairs Certification Tips Professional Certifications and Degrees 46
N RAPS Certification and RAPS Testing Professional Certifications and Degrees 1
F RAPS Annual Conference & Exhibition 2010 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
F RAPS Qualification - How Difficult to get are they? Professional Certifications and Degrees 4
M RAPS (Regulatory Affairs Professionals Society) Brazil LinkedIn Network Other Medical Device and Orthopedic Related Topics 0
Z RAPS RAC without Regulatory Experience - Break into the regulatory affairs industry Professional Certifications and Degrees 2
Quality Specialist AS9100D Approved Supplier List requirements and how to apply Supplier Quality Assurance and other Supplier Issues 7
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
C Can I apply First Time Yield (FTY) for several products or processes of different nature? Manufacturing and Related Processes 5
M How to apply IEC 62304 Problem Resolution Process for bugs discovered prior to release i.e. during initial development? IEC 62304 - Medical Device Software Life Cycle Processes 2
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
shimonv Worthwhileness for a small startups to apply for EUA (Emergency Use Authorization) for COVID-19 US Food and Drug Administration (FDA) 17
qualprod Records where apply and stop recording everything? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Operator protection - When to apply table 7, Dielectric strength test voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B How to apply external voltage to SIP/SOP IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
G Do HIPAA Rules Apply to a 3rd Party Logistics Shipper? Other US Medical Device Regulations 2
D Do purchasing controls apply to non-medical parts? ISO 13485:2016 - Medical Device Quality Management Systems 5
G Does pitch/increment/resolution of a ruled scale apply to measurement uncertainty as line item? Measurement Uncertainty (MU) 10
D Monitoring and measuring resources - Example of how section ISO 9001 7.1.5 would apply to a manufacture of software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Does ITAR apply to Exporters only? Other ISO and International Standards and European Regulations 6

Similar threads

Top Bottom