Rule 11 Question - CE approvals for software as well as the medical device

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
Our NB approved our device as Class IIa under MDD. The device is a blue tooth biometric sensor that communicates with a smart device application. We are being questioned why we didnt have two CE approvals for software as well as the device. Neither can work without the other which the FDA accepted. Comments?
 
Elsmar Forum Sponsor

JoshuaFroud

Involved In Discussions
#3
I'm interested as to who is questioning you?

I currently have a single CE application and technical file covering a physical device and its supporting PC based software. These are also both covered by the same 510(k).

We also have a a seperate stand alone piece of software that has its own CE Technical file. That while predominatly used in conjunction with our device it does not have to be. Which is why it has its on CE file.

Is the smart device application available without the device in any way?
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#4
The app can be downloaded freely via Google Play or the Apple app store but the app is useless without the bluetooth patch. There is no method to input data to the application other than our BT patch.

Its not a NB or regulatory body questioning us but a potential partner who wants to use our device in support of their drug development
 

Watchcat

Trusted Information Resource
#5
If the software was included in the information the NB reviewed to support certification (pet peeve here, NBs don't approve anything), then the answer is that the software was included in the one certification. If the software was not included, then I would look at it as a separate device and consult the MDD to see if it is a medical device that falls within its scope.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
One would be a medical device and the other an accessory to it. Since they are both useless without each other, and it's impossible to say which is what, it's almost an inevitable conclusion that they're both parts of one medical device and a single certification should cover both.
 

Watchcat

Trusted Information Resource
#7
If pharma companies are your target market, it occurs to me that you might want to look at your DoC and certificate as potential marketing materials. Pharma companies typically know little to nothing about device regulation, but they usually do know that software is a hot regulatory topic. From that perspective, their question isn't unreasonable, and this company might not be the last one to ask.

Different companies format their DoCs differently and different NBs do the same with their certificates, I think. Ideally, you would want your DoC to state exactly what it is that you are declaring conforms (i.e., "blue tooth biometric sensor and smart device app.") If you can get your NB to do the same on your certificate, even better.

Of course, given the state of things in the EU right now, it might not be easy (to put it mildly) to engage with your NB on this...
 
Last edited:
Thread starter Similar threads Forum Replies Date
R Nanomaterials used as coating on class I MD - rule 19 EU Medical Device Regulations 4
P MDR Rule 10 interpretation - Active Device EU Medical Device Regulations 3
N Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 11
K EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules? EU Medical Device Regulations 2
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
M Informational EU MDR Classification Rule 11 – what??? Medical Device and FDA Regulations and Standards News 9
A Please explain MDR Rule 11 to me EU Medical Device Regulations 67
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
Watchcat Informational Proposed Rule - De novos - 2019 Other US Medical Device Regulations 1
Q IATF rule for single site - Ingots from scrap metal recycling company IATF 16949 - Automotive Quality Systems Standard 0
R MDR Software Rule 11 Formal Interpretation EU Medical Device Regulations 7
M Informational US FDA – Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health – Final Rule Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Rule – Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices Medical Device and FDA Regulations and Standards News 0
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
S AQL Inspector's Rule - bring into CQE Exam? Professional Certifications and Degrees 5
M FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Medical Device and FDA Regulations and Standards News 0
M FDA News The FDA Issues Final Rule on Medical Device Classification Procedures Medical Device and FDA Regulations and Standards News 0
P The suspension rule and de-registration rule for a certified organization Registrars and Notified Bodies 0
bio_subbu India’s CDSCO Issues FAQ's on Medical Device Rule, 2017 Other Medical Device Regulations World-Wide 0
C Substance based Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 9
B Reclassification of Spinal Implants via Rule 8 (EU 2017/745) EU Medical Device Regulations 0
S Indian Medical Device Rule - January 29th, 2017 Other Medical Device Regulations World-Wide 33
R Technical Files Sampling Rule defined in NBOG 2009-4 EU Medical Device Regulations 2
Q Rule 5.2h - Site Separation - Audit Manday Calculation (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 17
M Final rule on use of symbols on labeling - Symbols without text under some conditions Other US Medical Device Regulations 12
P Is it a rule to fill in all the 5 why in order to get the actual root cause? Quality Tools, Improvement and Analysis 5
M Again ... about this IATF site extension rule... IATF 16949 - Automotive Quality Systems Standard 3
C Meaning of "direct diagnosis" (Annex IX, Rule 10) EU Medical Device Regulations 6
bobdoering Who says you can't calibrate a steel rule! Funny Stuff - Jokes and Humour 14
sagai Unified Device Identification Final Rule is out - September 2013 Other US Medical Device Regulations 13
S New FDA cGMP rule for Combinational Products Other US Medical Device Regulations 0
X FDA UDI (Unique Identification) amendment on 19 Nov 2012 - Date of 'final rule'? US Food and Drug Administration (FDA) 4
Ronen E New Establishment Registration and Device Listing Rule - August 2012 Other US Medical Device Regulations 32
K Are you wondering about FDA's UDI rule? Here's a non-exhaustive summary: Other US Medical Device Regulations 12
S US FDA Unique Device Identification (UDI) Proposed Rule 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
R Where does 20% Lot Qualification Rule Come from? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
Q Rule for ISO/TS16949 Triennial Audit of Multiple Sites (Remote Locations) IATF 16949 - Automotive Quality Systems Standard 2
Q Non Conformity in Audit: Missing Deputy Rule ISO 13485:2016 - Medical Device Quality Management Systems 10
P Employee Rule Book for a US based Packaging Company - Example wanted Career and Occupation Discussions 2
optomist1 GD&T Flatness Automatic Indirect Control Rule #1 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 20
A Rule for Complaint Definition - 21 CFR Part 820.3(b) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
G Explanation of Rule of Thumb (10:1) - Tolerance Zone or Digits Number Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
W MDDS Final Rule Published - February 15, 2011 US Food and Drug Administration (FDA) 0
H How the 50 Second Rule for an Operation was Derived Lean in Manufacturing and Service Industries 4
D FDA Proposes Rule Reclassifying Some Neurological and Physical Medicine Devices US Food and Drug Administration (FDA) 4
A P & F value in Minitab Statistical Studies (SPC) and the 8 points rule Using Minitab Software 7
C Calibration Accuracy - Can you apply the 10:1 rule in this case? General Measurement Device and Calibration Topics 15
W ANSI Z1.4 Switching Rule Applications Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
C Gage R&R 10:1 Tolerance to Gage Discrimination Rule Explanation Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
W Classification of Dental Implants - MDD 2.4. Rule 8 EU Medical Device Regulations 8

Similar threads

Top Bottom