If You Outsource Manufacturing of Your Medical Device or IVD, Who is Considered the Legal Manufacturer?
With the publication of Europe’s new Medical Device Regulation (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746), some companies that contract manufacture or relabel devices (OBL/PBL) are wondering if they will be considered the “legal manufacturer” of the device they sell. Much of the confusion around this issue stems from the assumption that there can be only one legal manufacturer. The current Medical Devices Directive (MDD 93/42/EEC) and In Vitro Devices Directive (IVDD 98/79/EC) are not entirely clear on the issue, but their successors (MDR and IVDR) make it crystal clear: one device can potentially have multiple legal manufacturers and each one of these manufacturers may have regulatory responsibility for that device.
Article 1, section 2(f) of the current MDD (93/42/EEC) can be interpreted a few ways, causing some confusion:
“Manufacturer means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name.”
* This depends on whether the legal manufacturer has the controls in place to control their contract manufacturer.
More Transparency Via EUDAMED
The EU, in an effort to circumvent the increasingly complex supply chain and issue of finger pointing, no longer places emphasis on who makes the device, but rather on who places devices on the market. Keeping in mind the definition of “legal manufacturer,” you can see the emphasis on traceability on display in Article 10, Paragraph 15 (and Article 10, Paragraph 14 of the IVDR):
“Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 30(1).”
Does that mean the name of the OEM needs to be on the labelling? No. Articles 27(1) and 30(1) refer to the EUDAMED database, so once that is operational in early 2020, the company placing their name on the labelling (legal manufacturer) of the device will need to include the name of the OEM in the registration process but not on the label or IFU.
Yes, There Can Be More Than One Legal Manufacturer But…
Under the MDR or IVDR, if you purchase a device or IVD from an OEM and you modify the Instructions for Use and labelling including company name on the labelling, you will be considered a legal manufacturer. When placing the device on the market and your company name appears on the labelling/packaging, you are considered a “legal manufacturer” and therefore must have permanent access to all technical documentation. Most OEMs are not going to allow that so, most likely, the MDR and IVDR will significantly curtail this business model. Read our obituary on OBL/PBL in Europe.
That means if you are a contract manufacturer or OEM that does not hold CE Marking certification for the device you manufacture, you are not responsible for maintaining compliant technical documentation because you are not considered a legal manufacturer in Europe. However, depending on your relationship with the legal manufacturer, technical documentation must be provided in order for the legal manufacturer to place the device/IVD on the market.
What About Importers and Distributors?
There are cases in which the obligations of manufacturers apply to importers, distributors, or other persons. Article 16 of the MDR and IVDR goes into more detail on this:
1 – A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
(a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;
(b) changes the intended purpose of a device already placed on the market or put into service;
(c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.
Need to get up to speed on the MDR or IVDR?
Oriel STAT A MATRIX offers a variety of training classes on medical device regulatory compliance. Two of our most popular classes include our EU MDR training and our IVDR training. We can also assist with any issues you might have related to Clinical Evaluation Reports, risk management and other European compliance issues.