Harmonization of device classification with EU MDD?

M

MIREGMGR

#1
The FDA occasionally says something about the benefits of harmonization with EU MDD, but I'm not aware of any efforts to harmonize the medical device classification systems. Anyone else know of activity in that direction?

I'm mostly writing this post out of frustration. We have thousands of different drape-and-cover, patient positioning and fluid capture products, and I'm working on a major project to verify that our internal regulatory-compliance stance for each project is of course properly compliant with FDA and EU MDD requirements, but also does not exceed those requirements in ways that result in significant additional costs. This of course is driven by increased pressure to be cost-competitive. I'm frustrated at the inefficiency of having two disparate systems, each of which has some obviously justified advantages, many of which we cannot take advantage of because we must comply to both systems.

The FDA often categorizes procedural accessories per the classification of the primary procedural device or modality, which often results in irrational patient protection and product costs. Thus an equipment-contamination-prevention sterile disposable equipment drape used in an invasive-procedure sterile field, but well characterized as having no direct or indirect patient contact, nonetheless is a Class II MMP or KKX requiring an expensive 510(k) and sometimes requiring proof of an acceptably low degree of laser-ignitability even when the device's intended use precludes proximity to lasers. On the other hand, a body-cavity-invasive sterile disposable camera cover is a Class I FTT/FTH/KQM/FWE/FWD/FWC/FWB/FWI/FWH and receives essentially no oversight even though it theoretically should require a greater-than-minimum degree of ISO10993 biocompatibility compliance.

But, to its credit, the FDA sometimes (albeit inconsistently) utilizes Class I designations and GMP exemptions to focus heightened regulatory documentation requirements on devices with greater risk, which at least conceptually are grouped into Class II.

The EU, on the other hand, groups practically all medical drape & cover, patient positioning and fluid capture devices into Class I, irrespective of significant and well-known differences in their degree of risk. And, there are no exemptions. Everything requires the same degree of compliance...which is good in that they don't irrationally exempt a few riskier devices, but bad in that their requirements impose far more regulatory compliance costs for hundreds of low-risk products compared to the FDA...which in many instances prevents us from taking advantage of the FDA's lower-cost requirements.

Grrrrrrr. :mad::bonk::frust:
 
Elsmar Forum Sponsor
M

MIREGMGR

#3
Thanks for the post. I'm not aware of any GHTF classification-harmonization activity or statements on the FDA's part since 2006, but I'm certainly motivated to keep my eyes open in that direction.

Though, of course, if the 2006 GHTF recommendations were to be adopted with requirements for retroactivity to existing devices, a lot more work would be involved than the project I'm currently struggling with. :rolleyes:
 
W

Watchwait

#5
Solution: Stop selling to the EU? :lmao:

No solace, but commensuration. We have a recently cleared Class II (FDA) Class IIa (MDD) device. It's a "remote presence" robot which is for all intents and purposes a communication device. We decided to couple it to an electronic (non-invasive but patient contact) stethoscope. The stethoscope is already cleared as a Class II device & you guessed it - we are now an "accessory" to that device assuming the same classification. Fortunately, we don't have the FDA/EU dichotomy - there both equally intrusive...;)
 
Thread starter Similar threads Forum Replies Date
bio_subbu GHTF Proposes New Harmonization of Medical Device Audits Other Medical Device Regulations World-Wide 0
V Medical Device Definitions outside GHTF (Global Harmonization Task Force) Other Medical Device Regulations World-Wide 2
M The FDA says device regulation will move toward harmonization... 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Ajit Basrur APEC Seminar on Harmonization of Medical Device Regulation (4-7, March) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
N Harmonization dates of IEC 60601-1-2:2014 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
shimonv Harmonization of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
J GHTF (Global Harmonization Task Force) SG2 Guidance Documents EU Medical Device Regulations 3
M US FDA Harmonization of Label Symbol Rules 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P GHTF's (Global Harmonization Task Force) Latest ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 5
M FDA Harmonization with Europe, Canada 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M GHTF (Global Harmonization Task Force) "Archived" Document question EU Medical Device Regulations 3
Ajit Basrur GHTF (Global Harmonization Task Force) release 2 final documents Other Medical Device Regulations World-Wide 2
M Auditing and harmonization? Determining what is an "industry standard" ISO 13485:2016 - Medical Device Quality Management Systems 6
somashekar AHWP (Asian Harmonization Working Party) Other Medical Device and Orthopedic Related Topics 2
Ajit Basrur Proposed documents from GHTF (Global Harmonization Task Force) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Harmonization of ANSI/AAMI PB70:2003, EN 13795? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Ajit Basrur Asian Harmonization Working Party to hold meeting on Nov 5, 6 in Delhi ISO 13485:2016 - Medical Device Quality Management Systems 0
T Harmonization date of IEC 60601-1 , 3rd Edition IEC 60601 - Medical Electrical Equipment Safety Standards Series 135
B ASEAN Harmonization Requirements - Particularly the Stability Calculation Food Safety - ISO 22000, HACCP (21 CFR 120) 0
A En 550/554 - The European Commission Standards Harmonization ISO 13485:2016 - Medical Device Quality Management Systems 2
T Device & Accessory, Components in device, or System EU Medical Device Regulations 0
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 3
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 0
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
M Sample record for verification performed by importers before placing a device on the market EU Medical Device Regulations 0
S IVD Device History Record ISO 13485:2016 - Medical Device Quality Management Systems 3
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
K How to handle GTINs for different configurations of one device with one part number? Other Medical Device Related Standards 0
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
C Multiple owners for one listed device Medical Device and FDA Regulations and Standards News 1
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
J Promoting and marketing of a non approved device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B Russian Device to US US Food and Drug Administration (FDA) 5
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom