technical regulations division...medical device directive 90/385/ec regarding active implantable...
TRANSCRIPT
![Page 1: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/1.jpg)
Market Surveillance Directorate
Technical Regulations Division
November 2016
![Page 2: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/2.jpg)
General Product Safety Act "producer" means:
(a) the manufacturer of the product, when he is
established in Malta, and any other person
presenting himself as the manufacturer by
affixing to the product his name, trade mark or
other distinctive mark, or
Malta Competition and Consumer Affairs Authority 2
![Page 3: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/3.jpg)
General Product Safety Act
(b) the person who reconditions the product; or
(c) the manufacturer’s representative, when the
manufacturer is not established in Malta or, if there is no representative established in Malta, the importer of the product; or
(d) others in the supply chain, in so far as their activities may affect the safety aspects of a product placed on the market.
Malta Competition and Consumer Affairs Authority 3
![Page 4: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/4.jpg)
General Product Safety Act
(1) Producers shall be obliged to only place
safe products on the market.
(2) The provisions of this Act shall apply
equally to products manufactured in or
imported into Malta.
(3) Any person who contravenes the
provisions of this article shall be guilty of an
offence under this Act.
Malta Competition and Consumer Affairs Authority 4
![Page 5: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/5.jpg)
Medical device directive
90/385/EC regarding Active Implantable Medical
Devices
98/79/EC regarding in vitro Medical Devices
93/42/EC regarding Medical Devices
Latest amendment: 2007/47/EC
• ISO 13485 Quality Management Systems for the
design and manufacture of medical devices
Malta Competition and Consumer Affairs Authority 5
![Page 6: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/6.jpg)
CE Marking
Malta Competition and Consumer Affairs Authority 6
![Page 7: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/7.jpg)
Declaration of Conformity
1. No xxxxxx (unique identification of the product);
2. Name and address of the manufacturer and his
authorised representative (where applicable);
3. “This declaration of conformity is issued under
the sole responsibility of the manufacturer (or
installer)”;
Malta Competition and Consumer Affairs Authority 7
![Page 8: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/8.jpg)
Declaration of Conformity 4. Object of the declaration (identification of product
allowing traceability. It may include a photograph, where appropriate);
5. Declaration that the object described is in conformity with the relevant Community harmonisation legislation;
6. References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared;
Malta Competition and Consumer Affairs Authority 8
![Page 9: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/9.jpg)
Declaration of Conformity
7. Where applicable, the notified body ...
(name, number)… performed …
(description of intervention) … and who
issued the certificate;
8. Signed for and on behalf of:
………………………….
(place and date of issue)
(name, function) (signature)
Malta Competition and Consumer Affairs Authority 9
![Page 10: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/10.jpg)
Declaration of Conformity
Supplier CPSU MCCAA
Malta Competition and Consumer Affairs Authority 10
![Page 11: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/11.jpg)
Declaration of Conformity
Malta Competition and Consumer Affairs Authority 11
![Page 12: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/12.jpg)
Declaration of Conformity
Malta Competition and Consumer Affairs Authority 12
![Page 13: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/13.jpg)
Relevant Applicable standards
Malta Competition and Consumer Affairs Authority 13
https://ec.europa.eu/gro
wth/single-
market/european-
standards/harmonised-
standards/medical-
devices_en
![Page 14: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/14.jpg)
Declaration of Conformity
Malta Competition and Consumer Affairs Authority 14
This is a Certificate
issued by a notified
body NOT a
declaration of
conformity
![Page 15: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/15.jpg)
Declaration of Conformity
Malta Competition and Consumer Affairs Authority 15
This is a Certificate
issued by a notified
body NOT a
declaration of
conformity
![Page 16: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/16.jpg)
Malta Competition and Consumer Affairs Authority 16
Amended directive
Model
numbers
Applicable standards Details of
notified body Details of
manufacturer
Date of
issue of DoC Signature &
Full name of
responsible
person
![Page 17: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/17.jpg)
Malta Competition and Consumer Affairs Authority 17
![Page 18: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/18.jpg)
Malta Competition and Consumer Affairs Authority 18
![Page 19: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/19.jpg)
Malta Competition and Consumer Affairs Authority 19
No mention of the
updated directive
Standards are
not dated Model numbers are
not listed
Certificate seems to be invalid
Important! Check
that there is an
EU representative
if the product is
being
manufactured
from outside the
EU
![Page 20: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/20.jpg)
Malta Competition and Consumer Affairs Authority 20
CE mark
present
Indication
that the
product is
sterile Expiry date
and Lot no.
Instructions/prec
autions where
applicable No model numbers
available
Address of
manufacturer and
supplier
![Page 21: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/21.jpg)
Rejected product
Malta Competition and Consumer Affairs Authority 21
![Page 22: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/22.jpg)
Technical File The technical documentation must allow
assessment of the conformity of the product with
the requirements of the Directive. It must include
in particular:
— a general description of the product, including
any variants planned and its intended use(s),
— design drawings, methods of manufacture
envisaged and diagrams of components, sub-
assemblies, circuits, etc.,
Malta Competition and Consumer Affairs Authority 22
![Page 23: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/23.jpg)
Technical File
— the descriptions and explanations necessary to
understand the above mentioned drawings and
diagrams and the operations of the product,
— the results of the risk analysis and a list of the
standards referred to in Article 5, applied in full or
in part, and descriptions of the solutions adopted
to meet the essential requirements of the
Directive.
Malta Competition and Consumer Affairs Authority 23
![Page 24: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/24.jpg)
Technical File — in the case of products placed on the market in a
sterile condition,
description of the methods used and the validation report,
— the results of the design calculations and of the inspections carried out, etc.; if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer.
Malta Competition and Consumer Affairs Authority 24
![Page 25: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/25.jpg)
Technical File
— the pre-clinical evaluation,
— the clinical evaluation in accordance with
Annex X
— the label and instructions for use.
Malta Competition and Consumer Affairs Authority 25
![Page 26: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/26.jpg)
Marie Antoinette Ellul
23952316
Thank you!
Malta Competition and Consumer Affairs Authority 26
![Page 27: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/27.jpg)
Classification of Medical devices
MDs are classified according to the risk posed:
Malta Competition and Consumer Affairs Authority 27
Risk
Increasing Notified
Body
Involvement
•CLASS I
- Is (sterile) and Im (measuring)
•CLASS IIa and IIb
•CLASS III
![Page 28: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/28.jpg)
Registration/Notification
Medical Devices Registration – Only
Class I that are placed on the EU market for
the 1st time through Malta
IVD Notification – General IVDs
Manufacturers Registration – Inform
MCCAA of your registered place of business
in Malta and description of devices
Malta Competition and Consumer Affairs Authority 28
![Page 29: Technical Regulations Division...Medical device directive 90/385/EC regarding Active Implantable Medical Devices 98/79/EC regarding in vitro Medical Devices 93/42/EC regarding Medical](https://reader034.vdocuments.us/reader034/viewer/2022042922/5f6e1b29bfb44f377b57d27e/html5/thumbnails/29.jpg)
New Medical Devices Regulations
• Revision of the 3 Medical Devices Directives has
been ongoing since 2012, replaced by 2 Medical
Devices regulations with the aim of increasing
the health and safety protection to EU citizens
• For Further information visit:
http://ec.europa.eu/growth/sectors/medical-
devices/regulatory-framework/revision_en
Malta Competition and Consumer Affairs Authority 29