Modification & combination of medical devices. When do I become the legal manufacturer?
The Medical Device Regulation (EU) 2017/745 gives pretty clear insights, definitions and answers to these important questions.
Thus, for all economic operators, manufacturers, importers, distributors, dealers, medical technicians, service engineers, customers and operators/users of medical devices it is essential to understand and obey these regulatory requirements.
The h/p/cosmos IFU instructions for use (operation manual) clearly states:
https://www.hpcosmos.com/en/contact-support/media-downloads/manuals
- Do not modify the device, configurations, accessories or software in any way.
- Do not connect any devices, accessories or software, not listed in “accessories / compatible devices”.
…
Unauthorized modification also includes modification of the labelling of a device, which is not allowed.
Connection to other devices or systems may form a new system which shall be subject to the relevant conformity assessment procedure pursuant to Article 52 of MDR.
So please also:
- Do not remove or modify any original label of a medical device or stick different labels over the original labels.
- Do not put additional labels and/or logos on the device which may give misleading impressions of the real legal manufacturer of the device.
- Do not combine any h/p/cosmos medical treadmill or medical device with a computer or other accessory if the external computer is necessary for measurement functions, data acquisition and signal processing of data related to treadmill functions, for example force measurement in the treadmill deck and/or pressure distribution measurement and/or biomechanics parameter measurement, etc.
The manufacturer h/p/cosmos can only affix a CE-mark for example on such a biomechanics treadmill, if the computer and software was installed at h/p/cosmos factory together with the treadmill and if all initial measurements of application data, accuracy checks, correct settings, electric safety checks and necessary system documentation including factory settings and initial measurement files have been performed and archived by the legal manufacturer h/p/cosmos in the respective electronic device file.
Unauthorized modifications and/or combinations, disregard of warnings, disregard of intended and forbidden use, safety precautions and also unauthorized or lack of maintenance and/or regular safety checks may lead to injuries or even death and/or can damage the device and will result in loss of any liability and warranty.
We all have to obey legal requirements in order to ensure safety of people and devices and in order to avoid prosecution consequences.
Competent experts and medical device consultants of h/p/cosmos are happy to help customers by answering relevant questions.
Extract from MDR Medical Device Regulation (EU) 2017/745
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=DE
Article 16
Cases in which obligations of manufacturers apply to importers, distributors or other persons
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.
article 22
Systems and procedure packs
1. Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:
(a) other devices bearing the CE marking;
(b) in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;
(c) other products which are in conformity with legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.
2. In the statement made pursuant to paragraph 1, the natural or legal person concerned shall declare that:
(a) they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers' instructions and have carried out their activities in accordance with those instructions;
(b) they packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together;
(c) the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation.
3. Any natural or legal person who sterilises systems or procedure packs referred to in paragraph 1 for the purpose of placing them on the market shall, at their choice, apply one of the procedures set out in Annex IX or the procedure set out in Part A of Annex XI. The application of those procedures and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged. The natural or legal person shall draw up a statement declaring that sterilisation has been carried out in accordance with the manufacturer's instructions.
4. Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers.
5. The systems or procedure packs referred to in paragraph 1 of this Article shall not themselves bear an additional CE marking but they shall bear the name, registered trade name or registered trade mark of the person referred to in paragraphs 1 and 3 of this Article as well as the address at which that person can be contacted, so that the person's location can be established. Systems or procedure packs shall be accompanied by the information referred to in Section 23 of Annex I. The statement referred to in paragraph 2 of this Article shall be kept at the disposal of the competent authorities, after the system or procedure pack has been put together, for the period that is applicable under Article 10(8) to the devices that have been combined. Where those periods differ, the longest period shall apply