Applicability of REACH in Medical Devices - Ophthalmic Surgical Adjuncts

[meddevstarter]

Thank you scott. This is helpful.

I am trying to get some info from my ISO 13485 registrar, will share details as soon as i get some information back.

 

[Ronen E]

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.

 

[meddevstarter]

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.

 

[meddevstarter]

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]

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.