MDR, RED and LVD - Should our device comply with them?

#1
Hi,
I have a problem with LVD and standard 62368-1, I'm not sure if our device should comply with them. We are designing a medical device with WiFi, so: our device has to comply with MDR and RED. According to article 3.1 of RED, any radio device has to comply with safety requirements set out in 2014/35/EE but with no voltage limits. It means that our device has to comply with RED, MDR and LVD. Essential requirements form LVD are covered by standard IEC 62368-1. Does it mean that our medical device shall comply with requirements from IEC 62368-1 or any other LVD harmonized standard? Are medical devices excluded from this standard because IEC 62368-1 is for "audio/video, information and communication technology equipment"?
I wasn't able to find any information about it. I would be very grateful for your help.
 
Elsmar Forum Sponsor

MikeKilkelly

Starting to get Involved
#2
Hi.. I am very interested in the answer to this. Did you get any information. I would also like to know if the move to the 62368-1 is mndated for products falling under the EMC Directive
 
#3
Hi,
I've informally spoken with an auditor from the notified body and according to him, any medical device has to comply with 62368-1 (most common) or other LVD harmonized standard.
 
Thread starter Similar threads Forum Replies Date
J Intervertebral body fusion cage, MDR Class II or Class III? EU Medical Device Regulations 4
F MDR GSPR Checklist template EU Medical Device Regulations 4
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
M EU MDR - Labilities when a device is discontinued from the Market EU Medical Device Regulations 1
S National registrations for MDR certified devices in absence of EUDAMED EU Medical Device Regulations 1
Z MDR Class Ir deadline (Reusable surgical instruments) EU Medical Device Regulations 27
B MDR equvalent device - can you use a medicine as an equivalent 'device' EU Medical Device Regulations 8
N Harmonized Standards for MDR Certification EU Medical Device Regulations 6
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
H EU MDR Economic Operator notifications? EU Medical Device Regulations 1
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
R Declaration of conformity as per EU MDR (2017/745) CE Marking (Conformité Européene) / CB Scheme 5
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 5
B Herbal ingredients MDR EU Medical Device Regulations 0
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
Kuldeep Singh Submission of MDR File - Partner Companies - Computed Tomography (CT) CE Marking (Conformité Européene) / CB Scheme 10
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
A MDR GSPR Checklist wanted EU Medical Device Regulations 3
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 2
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
B EU MDR Perscription product guidance EU Medical Device Regulations 1
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
H MDD CM, MDR manufacturer. 2020. Is it ok? EU Medical Device Regulations 1
E UK MDR brexit out of sync with EU MDR deadline? Other Medical Device Regulations World-Wide 4
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
dgrainger Medical Device News MDR postponed - link to Official Journal of the European Union (24-4-2020) EU Medical Device Regulations 2
K Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation Other Medical Device Related Standards 0
Ed Panek Medical Device News MDR Delayed 1 year (Posted 4/2020) EU Medical Device Regulations 9
dinaroxentool Former Class I device that is upscaled to IIa if the MDR is delayed EU Medical Device Regulations 2
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
J PPE, the MDR and EU 2016/425 EU Medical Device Regulations 4
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 6
dgrainger Informational Postponement of MDR - adopted by the Commission - April 2020 Medical Device and FDA Regulations and Standards News 3
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 8
F The EU Drafts Bill to Postpone MDR by a Year (3/2020) Medical Device and FDA Regulations and Standards News 2
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 6
M Estimating the benefit-risk ration under MDR EU Medical Device Regulations 1
F Will the EU postpone 2017/745 MDR Implementation - COVID-19 Impact Medical Device and FDA Regulations and Standards News 11
Ajit Basrur Physical Address on Product Labels (EU MDR perspective) EU Medical Device Regulations 2
B Notified Bodies for Software (MDR) EU Medical Device Regulations 1
P MDR Rule 10 interpretation - Active Device EU Medical Device Regulations 3
JoCam Certified Body Audit of MDR requirements EU Medical Device Regulations 4

Similar threads

Top Bottom