Applicability of REACH in Medical Devices - Ophthalmic Surgical Adjuncts

Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#12
We CE Mark and our Authorized Rep hasn't said anything about it, nor has our ISO 13485 registrar.
1. AFAIK EC REPs don't have any prescribed regulatory oversight obligations concerning the (EC-external) manufacturers that they represent. They merely serve as a primary go-to address for EC authorities, plus they have registration obligations in some contexts. What I'm getting at is that your EC REP is not necessarily a reliable source for understanding your EC regulatory obligations, as a manufacturer. Some are knowledgeable, but the most just provide the minimal service that the regulation requires of them.

2. Similarly, an ISO 13485 registrar wouldn't necessarily know too much about it. ISO 13485 certification can serve a MDD compliance, but it's not directly related to other EC directives.

But - we have a couple of customer who want a statement that we are REACH and RoHS compliant.
Customers are of course entitled to ask for whatever they desire.

REACH is a massive, complicated regulation and its applicability to a specific manufacturer/device combination depends on several factors.

@Meddevstarter:

It's difficult to pin-point the relevant obligations under REACH while having so little information about the company, the products and the marketing routes.
 
Last edited:
#13
Thank you Ronen for your input on this. It is much appreciated.

We have several products that contain phthalates. We label our devices with phthalates as applicable. If REACH is applicable to medical devices, we are subjected to double regulation. Using the navigator option on ECHA it becomes more complicated because your answers determine the obligations. If any one of your answer changes, your obligation changes.

My concern is doing double work thats coming off from double regulation. If I am already labelling my device with phthalate information for a medical use where the benefits outweigh the risk, do i still need to notify and request authorization from ECHA to fulfill one REACH requirement - assess impact on environment. 60(2) granting of authorization should not consider risks to human health, the risk to environment still needs to be considered.
 
#14
HI all,

We heard back from the registrar. Here is the feedback, not a straight arrow, but more round about. They basically called out compliance to MDD ER 7.5 and did not take a specific call on whether REACH is applicable or not.

Does not help much, but this comes from the registrar.
 

swathi.sp

Starting to get Involved
#15
Dear Folks,

We are into Radiotherapy & Radiology device manufacturing and all our products are CE certified under MDD and we have not installed any of our products in EU right now. My understanding if its manadate to comply for REACH means by this time our NB technical file reviewers would have been pointed out to comply for REACH, but not. Having compliance to REACH would really leverage me to tap EU market ? Can anyone throw some light on this.
 
Thread starter Similar threads Forum Replies Date
S Applicability of REACH Requirements RoHS, REACH, ELV, IMDS and Restricted Substances 7
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 8
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 6
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 5
V Applicability of IEC 62366-1 usability to resorbable bone substitutes IEC 62366 - Medical Device Usability Engineering 9
E Commission Regulation (EU) No. 207/2012 E-IFU Applicability EU Medical Device Regulations 3
M ROHS : Applicability for AIMDs RoHS, REACH, ELV, IMDS and Restricted Substances 2
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
M Applicability of Means of Protection, working voltage in an Automated External Defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Applicability of IEC 60950-1 Table K2 - Minimum clearances between circuits Various Other Specifications, Standards, and related Requirements 0
R Applicability of ISO 14708-3 RF Transmitter and Implantable RF Receiver Other Medical Device Related Standards 1
R Applicability of ISO 14708-3 - RF transmitter and implantable RF receiver Other Medical Device and Orthopedic Related Topics 1
M Oxygen enriched environment applicability - Operating table used in general surgeries in hospital IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E CB scheme applicability for battery powered medical devices CE Marking (Conformité Européene) / CB Scheme 0
I IATF 16949 - 8.4.2.3 - Applicability to Shipping Suppliers IATF 16949 - Automotive Quality Systems Standard 11
S CQI-12 - Applicability to Raw Materials Customer and Company Specific Requirements 1
C Applicability of ISO 9001:2015 Section 8.5 - Engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Applicability of EN 13795 for Incise Drape EU Medical Device Regulations 0
S Applicability of the standard IEC 60601-2-18 to an arthroscopy pump IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Partial non applicability of ISO 9001 Cl. 7.1.5 (not having services)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M User Interface of Unknown Provenance (UOUP) applicability IEC 62366 - Medical Device Usability Engineering 7
E Applicability of Low Voltage Directive (LVD) for 12V equipment CE Marking (Conformité Européene) / CB Scheme 4
Y Counterfeit Parts - AS9100 D Cl. 8.1.4 - Can I claim no applicability? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
M IEC 62304 Applicability - GUI Control Software IEC 62304 - Medical Device Software Life Cycle Processes 3
D Clarification of Applicability of TS 16949 Requirements to a Non-Automotive Business IATF 16949 - Automotive Quality Systems Standard 13
Richard Regalado Sharing a Statement of Applicability (SOA) for ISO/IEC 27001:2013 IEC 27001 - Information Security Management Systems (ISMS) 2
G Not quite old news: Statement of Applicability IEC 27001 - Information Security Management Systems (ISMS) 3
G Question on Statement of Applicability (SOA) IEC 27001 - Information Security Management Systems (ISMS) 2
L TS 16949 applicability for Supplier's Supplier IATF 16949 - Automotive Quality Systems Standard 8
R ISO 22000:2005 Clause 7.10.4 Withdrawal - Applicability and documentation required? Food Safety - ISO 22000, HACCP (21 CFR 120) 3
A Applicability of electrical safety standards to a dedicated PC IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
A Help me understand the applicability of 21 CFR Part 820.198 (Customer Complaints) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Y New Draft FDA Guidance for Applicability of GLP in Medical Device Submission Other US Medical Device Regulations 2
G TS 16949 applicability for Bulk Material Product IATF 16949 - Automotive Quality Systems Standard 25
Q Two AS9102 Applicability and Interpretation Questions AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
R HIPAA (Health Insurance Portability and Accountability Act) applicability Other US Medical Device Regulations 3
E Applicability of Defibrillator Energy Test to Implantable Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
P 7.1, 7.3 and APQP Requirements Applicability in Transfer Case IATF 16949 - Automotive Quality Systems Standard 1
A EN 60601-2-51 applicability to an ECG Event Recorder IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
K Applicability of ISO/TS 16949:2009 to Automotive Parts Manufacturers IATF 16949 - Automotive Quality Systems Standard 13
A AS9100C Clause 7.5 Applicability for Design House AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
Richard Regalado Definition SOA - Statement of Applicability Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
X Foreign Manufacturer Accreditation Certificate Applicability Japan Medical Device Regulations 8
Richard Regalado ISO 27001 Statement of Applicability and Some of my Thoughts IEC 27001 - Information Security Management Systems (ISMS) 4
R ISO/TS 16949:2009 Applicability to Military Vehicles? IATF 16949 - Automotive Quality Systems Standard 7
Q OEM (Original Equipment Manufacturer) PPAP Applicability Query IATF 16949 - Automotive Quality Systems Standard 4
D 21 CFR 820 Applicability to a Marketing Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
C Applicability of ISO 13485 for Medical TESTING Company ISO 13485:2016 - Medical Device Quality Management Systems 3
R MDD x Machine Directive - Statement of Non-Applicability EU Medical Device Regulations 16
Similar threads


















































Top Bottom