technical regulations division...medical device directive 90/385/ec regarding active implantable...

Market Surveillance Directorate

Technical Regulations Division

November 2016

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

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.


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.


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


CE Marking


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)”;


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;



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)



Supplier CPSU MCCAA


Relevant Applicable standards


https://ec.europa.eu/gro

wth/single-

market/european-

standards/harmonised-

standards/medical-

devices_en

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en












This is a Certificate

issued by a notified

body NOT a

declaration of

conformity


Amended directive

Model

numbers

Applicable standards Details of

notified body Details of

manufacturer

Date of

issue of DoC Signature &

Full name of

responsible

person


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


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

Rejected product


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.,


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.


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.


Technical File

— the pre-clinical evaluation,

— the clinical evaluation in accordance with

Annex X

— the label and instructions for use.


Marie Antoinette Ellul

[email protected]

23952316

Thank you!


mailto:[email protected]



Classification of Medical devices

MDs are classified according to the risk posed:


Risk

Increasing Notified

Body

Involvement

•CLASS I

- Is (sterile) and Im (measuring)

•CLASS IIa and IIb

•CLASS III

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


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


http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en





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