EU MDR - Liability Clause per article 31

sriramsl

Involved In Discussions
#1
Dear Experts - Ronen, Marcelo et al

In the EU MDR there is a liability clause as per article 31 :

"In view of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union and national law, it is appropriate to require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability under Council Directive 85/374/EEC ). Such measures should be proportionate to the risk class, type of device and the size of the enterprise. In this context, it is also appropriate to lay down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may have been injured by a defective device "

Does this mean that the manufacturers have to take an Product Liability Insurance? and will this be insisted by the Competent Authority before approval of the product?
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#3
The text from the OP is from the preamble ("Whereas"...")

The formal requirement is in Article 10 - General obligations of manufacturers

16. Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law.

Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.
Right now, it's really not clear what to expect from this requirement. In on hand, it does seem to require that the manufacturer complies with Directive 85/374/EEC (which they should already be doing). On the other hand, "measures in place to provide sufficient financial coverage" does seem to imply that insurance may be required.

I expect that we will have a guidance on this in the future.
 
Last edited:

yodon

Leader
Super Moderator
#4
Here's a link to the MDR online: http://eur-lex.europa.eu/legal-content/ENG/TXT/PDF/?uri=CELEX:32017R0745&from=EN

There are actually a couple of places where this is mentioned. Item 31 in the main body (?) is on p. 15:

"In view of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union and national law, it is appropriate to require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability under Council Directive 85/374/EEC1. Such measures should be proportionate to the risk class, type of device and the size of the enterprise. In this context, it is also appropriate to lay down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may have been injured by a defective device."

And then again in article 10, item 16, p. 84:

"Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law."
 

mikinnear

Starting to get Involved
#5
Ah yes,

Sorry with the mention of article 31 in the original post, that is exactly where I jumped to, on a further search I do see this text on page 15.

Kind regards,
Mike.
 

isolytical

Involved In Discussions
#6
Although not stated, it is clear that the word 'commensurate' strongly implies that one mitigation does not apply to all products. This is supported by the wording seen in the Directive(s). Thus to assume the PLI is required in absence of more complete product related information is erroneous.
 

sriramsl

Involved In Discussions
#7
Thank you Marcelo for your reply

As you said, hope we will get clarification on this from Regulatory Authority.
Regards
Sriram
 

RobertvanBoxtel

Involved In Discussions
#8
The requirement to have product liability Insurance is not new, also not for the medical devices in the EU.
The reference product liability Directive is applicable in these cases. And there might be more local member state requirements.

Also, look into Article 10.14 regarding information you will have to disclose to member states that can even end up at patients or Insurance companies.
The big unknown is what is sufficient coverage as there are no specifics on that, just depending on risk etc.
 

MiamiDM

Starting to get Involved
#9
Picking up on the requirement for liability insurance, an 'external consultant', not a NB, has recommended a review of liability insurance is covered in the Quality Manual or as part of Management Review.

Although representing 'best practice', I don't think reference to liability insurance in a QMS procedure is an expectation/requirement of the MDR.

Is my response reasonable?

Thoughts appreciated, thank you.
 

John Broomfield

Leader
Super Moderator
#10
Liability Insurance is an essential part of risk management for MD companies. So I’d expect companies to have a process in place for keeping this documented information up to date. If the auditee could not show me then I’d take this concern up with top management.
 
Thread starter Similar threads Forum Replies Date
goldenguo MDR/IVDR Insurance and Liability for Manufacturers, EU Representative and Importer EU Medical Device Regulations 3
Ed Panek MDR Liability Insurance EU Medical Device Regulations 1
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 3
Y Liability Insurance Requirements under the MDR - p. 15 (item 31) EU Medical Device Regulations 1
B MDR PSUR versus Canadian Summary report EU Medical Device Regulations 3
C MDR 2017/744 Article 22 EU Medical Device Regulations 3
K Sales of MDD devices with expired CE that are pending MDR certification EU Medical Device Regulations 4
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
D EU MDR Derogation EU Medical Device Regulations 0
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
M On-demand EU MDR Compliance toolkit with online training courses, templates & document management system Training - Internal, External, Online and Distance Learning 0
M EU MDR (GSPR Checklist) consolidated with TGA EP Checklist EU Medical Device Regulations 5
A PMSR or PSUR for legacy MDD-class I becoming MDR class-IIa EU Medical Device Regulations 7
H MDR clinical evaluation EU Medical Device Regulations 0
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
D Does the MDR article 10 (14) needs to be documented word for word in a Procedure? EU Medical Device Regulations 1
N Adding New Products during MDR transition period Manufacturing and Related Processes 1
L Internal Audits during the MDR Transition Period EU Medical Device Regulations 5
Z How to keep up with changes on applicable technical standards (EU MDR)? EU Medical Device Regulations 6
S OEM- Virtual Manufacturer contract MDR Quality Management System (QMS) Manuals 0
J TGA CER & EU MDR CER Requirements for Australia Other Medical Device Regulations World-Wide 3
G MDR DRAFT DoC EU Medical Device Regulations 7
F MDR Distributor EU Medical Device Regulations 6
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 1
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
M Declaration of conformity MDR EU Medical Device Regulations 10
dgrainger Informational Manual on Borderline for MDR/IVDMDR EU Medical Device Regulations 6
G MDR Requirements for Samples EU Medical Device Regulations 5
C Applicability of classification rule 9 under MDR EU Medical Device Regulations 6
H Is testing according to IEC 60601-1 & IEC 60601-1-2 mandatory for a device being registered under MDR? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Ed Panek MDR question - Meaning of Stability CE Marking (Conformité Européene) / CB Scheme 6
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
A EU MDR Annex II and Annex III CE Marking (Conformité Européene) / CB Scheme 6
N MDR requirments EU Medical Device Regulations 0
O MDD products under MDR certificate EU Medical Device Regulations 12
I Where to find MDR compliance device? EU Medical Device Regulations 6
J Conformity assessment route options under the UK MDR 2002 (2002 SI No. 618), as amended UK Medical Device Regulations 1
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
M MDR Legal requirements EU Medical Device Regulations 6
Ed Panek MDR Audit Comment EU Medical Device Regulations 9
J Minor / Major findings with MDR EU Medical Device Regulations 4
R MDR Clinical Evaluation Plan EU Medical Device Regulations 6
R EU MDR Article 22 applicability of medical device with components. EU Medical Device Regulations 4
K Qualified MDR internal auditor? EU Medical Device Regulations 8
J Clinical Evaluation For Instruments - Class I, Class Ir, Class Im, and Class IIa - EU MDR EU Medical Device Regulations 4
G MDR Translation Requirements in Member States EU Medical Device Regulations 8
R General Obligations of Importers under EU MDR EU Medical Device Regulations 3
V MDR – Article 65 – Clinical investigations on minors EU Medical Device Regulations 6
I MDR Audit: NC per MDR Annex IX Administrative provisions 8. EU Medical Device Regulations 6

Similar threads

Top Bottom