Hi,
I have not read or heard of any chatter about the Commission's position, specifically on the impact of 2017/745 to these Manufacturers, i.e. OBLs/VMs (Virtual Manufacturers) and OEMs. It is disappointing, as it would have been most helpful from the start to support a timely transition from MDD to MDR. Many businesses utilize this model and some of the businesses would not be viable without the model (i.e. OBL/VM has resource to market the device and OEM does not have the resource or OEM doesn't want all of the additional work that comes along with actually marketing the device). I have been following this topic and it seems that only the UK MHRA has provided the necessary support and guidance to these Manufacturers, to allow for them to continue working together, if still economically feasible, under EU MDR 2017/745.
Although the UK seems prepared to transition their medical device regulatory process out of the EU, they interestingly enough, invested significant resource and provided strong guidance and leadership in regards to preparing the EU for EU MDR 2017/745. The Commission's website currently does not provide reference to any UK MHRA MDR related guidance documents, but up until some time this past year, the UK MHRA was clearly contributing to preparing Manufacturers for EU MDR 2017/745 and this was evident by EU MDR guidance documents published on the Commission's website. To that end, the UK MHRA is the only Competent Authority who explicitly addresses and states the new expectations of the Virtual Manufacturer (aka Own Brand Labeller) and the OEM business relationship (originally published in 2017, last updated in April 2019), which can be found here:
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/793900/Virtual_Manufacturing__1_.pdfIn the guidance document, the OEM has the right to redact, limited, proprietary information from the Technical Documentation provided to the Virtual Manufacturer,
"Where the virtual manufacturer does not hold the rights related to product design, the notified body and competent authorities may accept a technical file from the virtual manufacturer that has redacted proprietary information as long as the redacted information is not essential for the purposes of the notified body or competent authorities assessing whether the medical device complies with the regulatory requirements. Redactions should be as limited as possible." (page 4).
Per the guidance document, the two manufacturers need to have a contractual agreement in place that explicitly establishes responsibility for critical to safety and transparency processes, e.g. post market surveillance and vigilance activities and expectations wrt interactions with Notified Bodies and Competent Authorities.
The guidance provides a route for product CE Certification for "Virtual Manufacturers" working with an OEM (or another manufacturer who owns the design of the product) and is intended for CE marked products, but was published by the UK MHRA (last updated April 2019).
Will the EU Commission implement?
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Lauren Harvey
Sr. RA Specialist
West Chester PA
United States
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Original Message:
Sent: 09-Oct-2020 11:21
From: Peter Miko
Subject: escape routes for CE-certification of current OBL manufacturers' devices
Dear Richard,
thank you for your always valuable thoughts.
regards
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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
Original Message:
Sent: 09-Oct-2020 06:20
From: Richard Vincins
Subject: escape routes for CE-certification of current OBL manufacturers' devices
Hello Peter,
I had to take a little bit to read through and maybe position my response properly since this area has a bit of interpretation which is not all completely aligned. My first statement is Own Brand Labelling (OBL) is no longer a viable business option. All of those virtual companies or distributors who used OBL as a way to bring different products to the market where they basically just changed the colour of the package and logo is no longer accepted. The virtual companies and distributors who put their name on the device/device labelling are now considered the legal manufacturer. Therefore, they need complete and full access to the technical documentation. There are many companies that will no engage in this type of business model. Why? What is to prevent another company or distributor to just start making the product themselves and take on the full regulatory responsibility.
The idea of equivalency is generally the same as well where you have a higher risk class device where you are claiming equivalency, the Regulation has a wonderfully mis-interpreted statement about having full access to the company's technical documentation (this is for Class III type devices where equivalency is being claimed). In most of the cases this is also not a viable business option. The only way this is usually viable is through the company's own technical documentation meaning it is a newer version of the device. It is still a viable option to let other companies have access to technical documentation though a very solid and secure agreement/contract should be in place.
In your first bullet point Peter, I agree the last two sub-bullet points would be viable options. This is with the understanding the so-called OBL company in the past who is now going to be considered the Manufacturer needs the full technical documentation and takes on the quality/regulatory responsibility. The first sub-point as mentioned, I do not think is a viable option as explained. The second sub-bullet is probably the best option to protect IP and the OEM is an actual OEM where they "sell" the product to another company to sell, but they keep a nice luxury deal to actually make the product without the headaches of regulatory issues (well at least most of them). The third sub-bullet I think is where a few companies/distributors are going if they want to keep selling these OBL or private label products.
As I commented, I do not think the second or third bullet point is viable option for most companies. Also the aspect of equivalency and having full access to technical documentation is limited to higher risk classification devices. In fact, just yesterday again I heard someone in a conference tell all the people listening that equivalency can only be done for any medical device if access to the full technical documentation is available. Which is still incorrect - I refer people to the guidance document MDCG has published and a previous post I made. So in fact, for some Class IIb devices and below, equivalency may be a viable option if sufficient technical information is publicly available for a device where demonstrating equivalency sufficiently can be made. So maybe for Class I and Class IIa device a private labelling scheme may still be a way to go for some companies. I might also mention again there are some creative ways companies can still do private labelling of finished medical devices, but it is really important a strong contract/agreement is in place between the different parties.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 08-Oct-2020 02:53
From: Peter Miko
Subject: escape routes for CE-certification of current OBL manufacturers' devices
Dear Colleagues,
Although my essay seems to be a little bit long and boring, I assure you, that it aims a hot topic and contains useful thoughts. It would be so good to know, what the experienced colleagues think about these thoughts.
regards
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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
Original Message:
Sent: 07-Oct-2020 07:03
From: Peter Miko
Subject: escape routes for CE-certification of current OBL manufacturers' devices
Dear Colleagues,
as the MDR / IVDR does not distinguish between OBL and other manufacturers, therefore OBL manufacturers are expected comply with the legal requirements, as any other manufacturer.
Would you agree with the following recommendations for the current OEM-OBL relationships in the EU:
- The regulatory basis of ensuring continuous product supply and gaining CE-certification under the MDR
- might be equivalency or
- the OEM should remain a contract manufacturer only without CE-certification but with ISO 13485 certificate and the OBL buys the know-how, develops and owns the technical documentation,
- or the product (if allowed by law) is duplicated by reverse engineering and the OBL develops and owns the technical documentation. The relationship with the OEM is cancelled.
- In case the equivalency route is selected, the OBL manufacturers of implantable devices and class III devices should sign a contract with the OEM, that allows full access to the technical documentation of the OEM on an ongoing basis according to 61(5). The equivalent device of the OEM should be certified under the MDR. (according to the MDCG 2020-05 p.12/20 it will not be possible to claim equivalence to implantable devices and class III devices certified with respect to the Directives 93/42/EEC or 90/385/EEC).
- OBL manufacturers of devices other than implantable devices and class III devices and where the manufacturer wants to claim equivalence, MDR Article 61 (3) is applicable. As this requirement does not specify whether the device is presumed to be marketed within the EU, it will be possible to claim equivalence to a device certified with respect to the Directives 93/42/EEC or 90/385/EEC or the MDR. Equivalence can be* claimed to a device that is not CE-marked, provided all relevant MDR requirements regarding equivalence and clinical evaluation can be met. This includes that the manufacturer shall have sufficient level of access to the data relating to devices with which they are claiming equivalence. This may be ensured by a contract signed with the OEM. The extent of the access is product specific.
All this is based on MDCG 2019-06 v2 and 2020-05. Can be* is missing from the original text's sentence on page 13/20 of the MDCG 2020-05.
regards
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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
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