Article 61 - MDR Clinical Investigation Requirement

Sammy23

Starting to get Involved
#1
Hi,

I'd like to better understand the Clinical Investigation mandate under Art. 61. In my reading - I understand that equivalence to another manufacturers device is likely impossible. However, where a manufacturer claims equivalence to it's own devices (Class III) this is an acceptable path to go the clinical eval route.

We are developing a newer version of a device currently approved under 93/42/EEC. We intend to go under the MDR with this newer version - and believe we'd be able to prove equivalence from a biological, technical and clinical route. Conducting an animal study and biocomp testing.

For a new Class III device (not novel) - how does Art. 61 (a) apply? Is this saying that we can't go the clinical eval route since the new version of the device is not an MDD device?

Art. 61(a):
6. The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices
and class III devices:
(a) which have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or
Directive 93/42/EEC and for which the clinical evaluation:
— is based on sufficient clinical data, and
— is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of device, where
such a CS is available


Any guidance would be helpful!!
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Was hoping someone would jump in on this. Since nothing yet, I'll give it a go as best I can (with the caveat that this isn't an area I'm strong in).

First off, uncouple "clinical evaluation" from "clinical investigation." The former is the subject of the article and the latter is one method for getting clinical data. They're different things.

For an initial product launch, you may or may not be required to do a clinical study (investigation). It may be possible / acceptable to establish clinical evidence without a trial. Article 61.6(a) is saying that if you had a device cleared under the MDD and you have sufficient clinical data, you aren't required to conduct a clinical investigation.

Things seem to be pretty fluid these days. You'd best discuss your approach (early) with your NB and get their take on whether it's acceptable or not.
 
#3
As you obviously have full access to the Technical Documentation to the previous version of your own device, and can justify equivalence using the criteria you specify, there should be no need for clinical investigation (trial).

As the previous poster points out, there is always the need for clinical evaluation which is not the same thing as clinical investigation. A clinical evaluation may or may not include a clinical investigation (trial).
 

dgrainger

Trusted Information Resource
#4
You always have to perform a CE but can exclude a CI if:
  • It's on the market under the directives - (6a) or
  • It's in the list of exclusions (6b)
  • It's a modification of a device already on the market (4)
Your NB will check.

Does your "newer version" qualify as a modification?
 

Sammy23

Starting to get Involved
#5
You always have to perform a CE but can exclude a CI if:
  • It's on the market under the directives - (6a) or
  • It's in the list of exclusions (6b)
  • It's a modification of a device already on the market (4)
Your NB will check.

Does your "newer version" qualify as a modification?
You always have to perform a CE but can exclude a CI if:
  • It's on the market under the directives - (6a) or
  • It's in the list of exclusions (6b)
  • It's a modification of a device already on the market (4)
Your NB will check'

Does your "newer version" qualify as a modification?
Thank you all for the helpful suggestions. The 'newer' version may qualify as a modification - I say may as the intended use will be the same, but will have an additional design feature allowing for an expanded intended use. The device is a guide wire, and CI for these devices are rare and do not seem to make much sense. We'd be forced to use our device as the equivalent device as the MDR is not allowing equivalence to another manufacturers device* (even though our modified device is most equivalent to another manufacturers device).

*Unless the other manufacturer would be me happy to agree to their competitor having access to their tech doc. Weird.
 

Sammy23

Starting to get Involved
#6
Was hoping someone would jump in on this. Since nothing yet, I'll give it a go as best I can (with the caveat that this isn't an area I'm strong in).

First off, uncouple "clinical evaluation" from "clinical investigation." The former is the subject of the article and the latter is one method for getting clinical data. They're different things.

For an initial product launch, you may or may not be required to do a clinical study (investigation). It may be possible / acceptable to establish clinical evidence without a trial. Article 61.6(a) is saying that if you had a device cleared under the MDD and you have sufficient clinical data, you aren't required to conduct a clinical investigation.

Things seem to be pretty fluid these days. You'd best discuss your approach (early) with your NB and get their take on whether it's acceptable or not.
Thanks so much for this clarification. If we are trying to get approval for a device (which is a modified version of a device approved under MDD), is the view that this modified version is not a device approved under MDD?
 
Thread starter Similar threads Forum Replies Date
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 6
T EU MDR Article 61- Clinical Evaluation EU Medical Device Regulations 2
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
M MDR Article 22 Interpretation EU Medical Device Regulations 3
L EU MDR Article 86 PSUR EU Medical Device Regulations 1
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 6
C Article 16 MDR - Medicine packaged together with Medical Device EU Medical Device Regulations 0
F MDR system/procedurepack (article 22) with device acc. to MDD and MDR CE Marking (Conformité Européene) / CB Scheme 2
N EUDAMED postponement and compliance with Article 120 (3) MDR for Legacy Devices EU Medical Device Regulations 8
R MDR Article 22: Systems and procedure packs Other Medical Device Regulations World-Wide 12
M Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re Medical Device and FDA Regulations and Standards News 7
F Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements EU Medical Device Regulations 8
E MDR Article 117 / Impact to New Marketing Authorization Applications Other Medical Device Regulations World-Wide 1
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
T MDR article 22 - System of 2 CE products and validation / usability? EU Medical Device Regulations 10
T Clarification on MDR - Article 18(d) - Implant Card EU Medical Device Regulations 14
M Is MDR Article 61(5) Unrealistic? EU Medical Device Regulations 9
D Responsible for regulatory compliance (Article 15 of MDR 2017/745) Quality Manager and Management Related Issues 4
S EU MDR - Liability Clause per article 31 EU Medical Device Regulations 22
dgrainger Informational MHRA guidance on CE UKNI - Article 5.5 - 2021-02 EU Medical Device Regulations 0
K Article 18: Implant Card and information to be communicated. EU Medical Device Regulations 5
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
S Article 22 Procedure Pack Labelling EU Medical Device Regulations 4
S Translational Requirements - Article 120 EU Medical Device Regulations 5
K Expected lifetime of the device-Article 18 EU Medical Device Regulations 4
T Implant Card - Article 18.1(a) and MDCG 2019-8 clarification EU Medical Device Regulations 3
P Economic operator responsibilities - when the Importer is also Distributor - Article 13 EU Medical Device Regulations 1
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
K Article 18 in the Implant Card - Expected lifetime of the device EU Medical Device Regulations 3
T Sample of 1st Article Inspection Report wanted APQP and PPAP 3
F 2017/745 Article 31 Single Registration Number Medical Device and FDA Regulations and Standards News 5
Sidney Vianna Interesting Discussion Interesting article form the UNIDO Magazine - CSR: a wolf in sheep’s clothing? Sustainability, Green Initiatives and Ecology 16
M Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o Medical Device and FDA Regulations and Standards News 2
A Interpretation of Article 16 (2b) - Packaging, samples and Certificate EU Medical Device Regulations 10
G First Article Submission (Destruction of parts) APQP and PPAP 2
K First Article Inspection (FAI) - Equipment used - Dimensions vs. Go/No-Go ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
C Is a First Article Inspection (FAI) Procedure required by ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Medical Device and FDA Regulations and Standards News 0
K Article 23 (Parts and components) - Economic Operator EU Medical Device Regulations 1
Marc As the earliest wind farms age - Dec 2018 Ars article Sustainability, Green Initiatives and Ecology 4
Sidney Vianna Interesting Discussion Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate? Canada Medical Device Regulations 0
M FAI AS9102 - What does a First Article Inspection cover? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
C AS9100, Clause 8.5.1.3 - First Article Inspection Costs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
A MedMMAP Article - August 2018 MedAccred Industry Group Program 0
A MedAccred Program - article MedAccred Industry Group Program 2

Similar threads

Top Bottom