2. Proposal for a Regulation on medical devices and Proposal for a Regulation on in vitro diagnostic medical devices
Key Provisions and GIRP Assessment
Based on the medical devices proposal (text in black)
Numbering and differences in text with the in vitro diagnostic are highlighted (text in green)
GIRP comments (text in red)

3. Preamble

4. Activities of Distributors
Preamble 24(a) 20(a)
“For the purpose of this Regulation the activities of distributors include acquisition, holding and supplying of (in vitro diagnostic) medical devices”
Comment:
Details the context in which to consider the definition of “distributor” in Art. 2(22) Art. 2(19).
Wholesaler falls within the scope of the regulation.

5. Article 2 - Definitions

6. Article 2 - Making Available on the Market
“ ‘making available on the market’ means any supply of a device, other than an investigational device (other than a device for performance study), for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;”
Comment:
Mentioned as part of scope of activity of a “distributor” - see Art. 2(22) 2(19)

7. Article 2 - Placing on the Market
“ 'placing on the market' means the first making available of a device, other than an investigational device (other than a device for performance study), on the Union market;”

8. Article 2 – Putting into Service
“ ‘putting into service ’ means the stage at which a device, other than an investigational device (other than a device for performance study), has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;”
Comment:
Mentioned as part of scope of activity of a “distributor” - see Art. 2 (22) 2 (19)

9. Article 2 – Importer Article 2(21) 2(18)
“ ‘importer’ means any natural or legal person established within the Union who places a device from a third country on the Union market;”
Comment:
To be considered in the context of Article 12(2c) 12(2c) which requires a “distributor” to check that the products received from an “importer” contain certain information as outlined in Article 11(3) 11(3).

10. Article 2 – Distributor Article 2(22) 2(19)
“ ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market, up until the point of putting into service;
Comment:
Definition amended from original proposal to now include “up until the point of putting into service” - see Art. 2(18) 2(15). Reference to “makes a device available” remains - see Art. 2(16) 2(13)
Wholesalers within the scope of the Regulation.

11. Article 2 – Economic Operator
“ ‘economic operators’ means the manufacturer, the authorised representative, the importer, and the distributor; and the person referred to in Article 20(1) and 20(3);” (the latter does not appear in the in vitro diagnostic regulation)
Comment:
Note that it includes “distributor” as defined in Art. 2(22) Art. 2(19).
Distributors fall within scope of obligations placed on economic operators.

12. Article 2 – User Comment:
Article 2(25) Article 2(22)
“ ‘user ’ means any healthcare professional or lay person who uses a device;”
Comment:
“healthcare professional (and also “healthcare institution”) not specifically defined within the Regulation.

13. Article 11 – General obligations of importers

14. Article 11 – General obligations of importers
“Importers shall indicate their name, registered trade name or registered trade mark and the address of their registered place of business at which they can be contacted and their location can be established on the device or on its packaging or in a document accompanying the device. …”
Comment:
Art. 11(3) 11(3) is referenced in Article 12(2c) 12(2c) as part of the general obligations on distributors.
Important to note that this does not fall within scope of sample check by distributors as mentioned in Art 12(2) 12(2).

15. Article 12 – General obligations of distributors

16. Article 12 – General obligations of distributors
“In the context of their activities, when making a device available on the market, distributors shall act with due care in relation to the requirements applicable.”
Comment:
Due care in relation to applicable requirements.

17. Article 12 – General obligations of distributors
“Before making a device available on the market distributors shall verify that the following requirements are met:
a) the device has been CE marked and that the declaration of conformity of the device has been drawn up;
b) the product is accompanied by the information to be supplied by the manufacturer in accordance with Article 8(7);
c) for imported devices, the importer has complied with the requirements set out in Article 11(3);
d) that, where applicable, a Unique Device Identification has been assigned by the manufacturer.”

18. Article 12 – General obligations of distributors
Comment:
(a), (b) and (d) – remains from previous Presidency amendments.
(d) softened to refer to check only if UDI assigned
New point (c) added, reference to Article 11(3) 11(3) – but is not part of the representative sampling method for 12(2 a, b, and d) 12(2 a, b, and d).
Consider the number of products that a distributor receives from an “importer”, consider the implications of checking for the information mentioned in Article 11(3) 11(3)

19. Article 12 – General obligations of distributors
“In order to meet the requirements referred to in subparagraphs (a), (b) and (d) the distributor may apply a sampling method representative of products supplied by that distributor.”
 Comment:
(a), (b) and (d) – representative sampling, GIRP lobby success
Concern that new point (c) added, reference to Article 11(3) – not part of the sampling process.
(d) Softened – to only check a UDI is assigned
Consider the number of products received from importers and the implication with having to check all elements of information.

20. Article 12 – General obligations of distributors
“ Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer. ”
Comment:
Storage and transport conditions to be maintained according to conditions set by the manufacturer.

21. Article 12 – General obligations of distributors
Distributors to inform manufacturer (importer or representative) if he believes a device is not in conformity with this Regulation and co-operate with the manufacturer (importer or representative) to ensure corrective action to bring that device into conformity, withdraw or recall it. If serious risk suspected, the distributor should inform the competent authorities.
Article 12(5) 12(5)
Distributors to communicate complaints from healthcare professionals, patients or users to manufacturer and keep a registry of such, recall and withdrawals.
Article 12(6) 12(6)
Distributors to provide information and document to authorities to demonstrate the conformity of a device.
Comment: noteworthy provisions

22. Identification within the supply chain

23. Identification within the supply chain
Article 23(1) 21(1)
“Distributors and importers shall co-operate with the manufacturer or authorized representative to achieve an appropriate level of traceability of devices.”
Comment:
General requirement for distributors – within scope of traceability system

24. Identification within the supply chain
Article 23(2) 21(2)
“Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 8(4) 8(4):
any economic operator to whom they have directly supplied a device;
any economic operator who has directly supplied them with a device;
any health institution or healthcare professional to whom they have directly supplied a device.”
Comment:
Distributor falls within definition of “economic operator”, keep records for 10 years after last device covered by the declaration of conformity has been placed on the market; 15 years for Class III active implantable devices.

25. Unique Device Identification System

26. Unique Device Identification system - Composition
Article 24(1) 22(1)
“The Unique Device Identification (‘UDI’) system … shall consist of the following:
a) production of a UDI that comprises the following:
(i) a device identifier (‘DI’) specific to a manufacturer and a device, …
(ii) a production identifier (‘PI’) that identifies the produced device's unit and if applicable the packaged devices …;
b) application of the UDI on the label of the device or on its package;
c) storage of the UDI by the economic operators, the health institutions and the healthcare professionals, according to the conditions established in paragraphs 5 5, 5aa 5aa and 5a 5a respectively;
d) establishment of an electronic system on UDI (‘UDI database’) according to Article 24a 24a.”

27. Unique Device Identification system - Composition
Article 24(1) 22(1)
Comment:
UDI – 2 parts; DI (product level, static), PI (unit level, dynamic)
UDI directly on device or packaging (including higher levels)
UDI to be recorded for “active implantable devices” only - see Art 24(5) (does not appear in the in vitro diagnostic regulation)

28. Unique Device Identification system – Operation of UDI system
Article 24(2) 22(2)
“ The Commission shall designate one or several entities that operate a system …:
a) the entity is an organisation with legal personality;
b) … is adequate to identify a device through its distribution …;
c) .. UDIs conforms to … international standards;
d) … gives access … to all interested users …; …”
Comment: UDI system set-up and managed by legal entity

29. Unique Device Identification System – UDI carrier on higher levels of packaging
Article 24(4) 22(4)
“The UDI carrier shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging do not include shipping containers.”
Comment:
UDI on all higher levels of packaging, but not on storage containers

30. Unique Device Identification system - economic operator to store and keep UDI
Article 24(5) 22(5)
“Economic operators shall store and keep, preferably by electronic means, the UDI of the devices which they have supplied or they have been supplied with, if they belong to :
class III implantable devices; (does not appear in the IVD proposal)
the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 7 ”
Comment:
UDI record for distributor for Class III active implantable devices
UDI record for other classes Class I, Class IIa and Class IIb only after EC implementing act, taking accounts of issues such as a risked based approach, etc…

31. Unique Device Identification system - Health institutions shall store and keep UDI
Article 24(5aa)
“Health institutions shall store and keep preferably by electronic means the UDI of the devices which they have supplied or they have been supplied with if they belong to class III implantable devices.”
“For devices other than class III implantable devices, Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices which they have been supplied with.”
Article 22(5aa)
“Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices which they have been supplied with.” 
Comment:
“Health institutions” subject to same requirement as “economic operators”, however, “healthcare institutions” are not defined.

32. Unique Device Identification system - Health institutions shall store and keep UDI
Article 24(5a) 22(5a)
“Member States shall encourage, and may require, health care professionals to store and keep preferably by electronic means, the UDI of the devices which they have been supplied with.”
Comment:
“Health institutions” subject to same requirement as “economic operators”, but “healthcare professionals” only encouraged, or may be required by Member States to do so.
“Healthcare professionals” are not defined.

33. Unique Device Identification system - Healthcare professionals shall store and keep UDI
Article 24(7) 22(7)
“The Commission may by means of implementing acts specify … :
the determination of the devices, categories or groups of devices to which the obligation laid down in paragraph 5 5 shall apply;
the specification of the data to be included in the UDI production identifier (‘UDI-PI’) of specific devices or device groups; ”
Comment:
EC implementing act required to extend scope of application of UDI to other devices (beyond Class III active implantable devices) categories or groups of devices and the scope of the included data on the PI.

34. Electronic system on registration of economic operators
Article 25(1b) 23(1b)
“Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available in their territory.”
Comment:
Registry of distributors at the discretion of the Member States (voluntary).

35. European Healthcare Distribution Association
Rue de la Loi 26, 10th floor, box 14
B-1040 Brussels, Belgium T F E W