Presentation about EU Medical Devices Regulation Packaging requirements

1. EU MDR
PACKAGING
COMPLIANCE
Q1 Medical Device Packaging
Conference 10 November 2020
Erik Vollebregt
www.axonadvocaten.nl

2. Agenda
• Integrity of sterile packaging clearly evident to end-users
• Validating packaging methods & technical documentation
• Impact on critical suppliers of packaging materials & NB inspections
• Significant changes
• Repackaging regime
• Packaging and the exits
• Claims on the packaging

3. Integrity of sterile packaging
clearly evident to end-users
Annex I, 8.3 MDD -> Annex I, 11/4 MDR – two new elements:
• Element 1: remain sterile, under the transport and storage conditions
specified by the manufacturer, until that packaging is opened at the point
of use
• Packaging must be designed for storage and handling conditions
within end user / customer operations and storage
• Validate
• Active monitoring of packaging performance at user is now a
PMS requirement part of new PMS system (see Annex III, 1.1
(a) and (b) MDR

4. Integrity of sterile packaging
clearly evident to end-users
Annex I, 8.3 MDD -> Annex I, 11/4 MDR – two new elements:
• Element 2: It shall be ensured that the integrity of that packaging is
clearly evident to the final user
• “clearly evident” - pleonasm or not?
• Evident – can be unequivocally established
• Clear – easy to detect
• Annex I 23.3 (j) MDR – instruction to check IFU if sterile
packaging is opened before use
• Annex 23.4 (l) IFU requirements for instructions in that
case

5. Validating packaging methods &
technical documentation
Annex I, 11.7 MDR:
• “Packaging systems for non-sterile devices shall maintain the
integrity and cleanliness of the product”
• (Annex I, 8.6 MDD: “Packaging systems for non-sterile devices
must keep the product without deterioration at the level of
cleanliness stipulated”)
• Different criterion – change your technical documentation on this point!

6. Validating packaging methods &
technical documentation
Annex I, 23.2 MDR:
• Particulars that must appear on sterile packaging (i.e. ON
packaging
• (a) an indication permitting the sterile packaging to be recognised
as such,
• (b) a declaration that the device is in a sterile condition,
• (c) the method of sterilisation,
• (d) the name and address of the manufacturer,
• (e) a description of the device,
• (f) if the device is intended for clinical investigations, the words
‘exclusively for clinical investigations’,

7. Validating packaging methods &
technical documentation
Annex I, 23.2 MDR:
• Particulars that must appear on sterile packaging (i.e. ON
packaging
• [cont’d]
• (g) if the device is custom-made, the words ‘custom-made device’,
• (h) the month and year of manufacture,
• (i) an unambiguous indication of the time limit for using or
implanting the device safely expressed at least in terms of year
and month, and
• (j) an instruction to check the instructions for use for what to do if
the sterile packaging is damaged or unintentionally opened before
use.
• Change your technical documentation!

8. Validating packaging methods &
technical documentation
Annex II – ‘official’ technical documentation template
Section 2 requires a complete set of:
• the label or labels on the device and on its packaging, such as
• single unit packaging,
• sales packaging,
• transport packaging in case of specific management conditions,
• in the languages accepted in the Member States where the device is
envisaged to be sold
• Packaging translations must have been made when technical
documentation goes in!

9. Validating packaging methods &
technical documentation
• Revisit submission strategy for submission of documentation for
technical documentation review (below: BSI Best Practice guidelines for
technical documentation submission)

10. Validating packaging methods &
technical documentation
• Revisit submission strategy for submission of documentation for
technical documentation review

11. Critical packaging suppliers
• Will be subject to mandatory unannounced notified body audits
• Annex IX, section 3.4
• Annex VI part C 2.3: “Only the manufacturer may place the UDI on the
device or its packaging.”
• Switching critical packaging supplier in MDR grace period can invalidate
(AI)MDD certificate if leads to a significant change (see also next slide)
• Change of packaging design with impact to sterilization (MDCG
2020-3, chart E)

12. Packaging
and
significant
changes
• MDCG 2020-3, chart E:
• Significant change =
certificate immediately
void, no discussion

13. Economic operators and
packaging
Article 13 (3) MDR:
• “Importers shall indicate on the device or on its packaging or in a
document accompanying the device their name, registered trade name
or registered trade mark, their registered place of business and the
address at which they can be contacted, so that their location can be
established.”
Importer agreement must contain language about how the importer is going
to meet this requirement and what happens if packaging is compromised in
the process.

14. Repackaging regime
• Article 16 MDR
• guidance coming
• Importer/distributor needs process (article 16 (3) MDR)
• In case of sterile devices process should cover how to maintain
sterility or negative consequences (article 16 (2) (b) MDR)
• Repacking may not compromise UDI on packaging (MDCG 2018-
6)
• Repackaging symbol under ISO 15223-1/ed 4

15. Packaging and the exits
• More of a labeling issue than a packaging issue, but still affects
packaging
• After exits, country (UK, Switzerland, Turkey) can diverge in
packaging
• Packaging and labeling processes are intertwined (see also article
2 (13) label definition – includes packaging)

16. Prepare for exits
• Brexit – legal deadline 31/12/20
• May be hard, may be
somewhat less hard – time is
running out for anything less
than a hard Brexit
• Watch international political
developments
• Swixit – maybe 26/05/21
• Positive September 2020
referendum likely too late for
IFA signoff
• Turkxit – maybe 26/05/21
• Commission: ‘this is being
worked on’ but “politics”
16

17. Claims on the packaging
• Article 2 (13) – definition of
label includes information
appearing on the
packaging of individual and
multiple units

18. Claims on packaging
• Article 7 MDR prohibition of misleading patient – end user ties back into
labeling (which includes packaging (art 2 (13) MDR) and IFU and many
other processes (example below)

19. Thanks for your attention!
Erik Vollebregt
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
M +31 6 47 180 683
E erik.vollebregt@axonlawyers.com
@meddevlegal
B http://medicaldeviceslegal.com
READ MY BLOG:
http://medicaldeviceslegal.com