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Medical Devices

Active Implantable Medical Devices | Electro Medical Equipment used in Veterinary Medicine | In Vitro Diagnostic Medical Devices | Medical Devices | Consultations

Overview

Medical devices have become an increasingly important health care area in relation to their impact on health and health care expenditure. The sector covers some 8000 types of products, ranging from simple bandages and spectacles, through life maintaining implantable devices, equipment to screen and diagnose disease and health conditions, to the most sophisticated diagnostic imaging and minimal invasive surgery equipment.

There are 3 main European Directives that govern medical devices (93/42/EEC, 90/385/EEC and 98/79/EC). This regulatory framework aims at ensuring that:

  1. Only safe devices are placed on the European market,

  2. Devices in conformity with the Directives have total market access and there is free movement of goods across the EU,

Industry remains competitive in order to encourage innovation and investment in this sector

This section offers you information on the existing legislation concerning medical devices and on the closed, ongoing and upcoming consultations that are being prepared by the Malta Standards Authority.  Links to guidance documents, forms and FAQs are also available.

Further information on medical devices can also be found on the Commission's enterprise website.

 
Active Implantable Medical Devices

Legal Notice 66 of 2001

Title:

Active Implantable Medical Devices Regulations, 2001

Act:

Product Safety Act (Cap. 427)

Transposes:

Council Directive 90/385/EEC of 20th June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.

Link to Directive:

http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31990L0385:EN:HTML

Entry into Force:

1st April 2001

Publication:

Government Gazette of Malta No. 17,078 of 30th March 2001

Applies to:

Active Implantable Medical Devices such as implantable cardiac pacemakers, cochlear implants, implantable defibrillators, bladder stimulators and implantable active drug administration devices.

Aim of Regulation:

A harmonized European law ensuring that in each Member State, active implantable medical devices give patients, users and other persons a high level of protection and achieve the intended level of performance when implanted in human beings and ensuring free movement of devices within the European Union.

Amends:

Not applicable

Repeals:

Not applicable

 

Electro Medical Equipment used in Veterinary Medicine

Legal Notice 90 of 2002

Title:

Electro-Medical Equipment used in Veterinary Medicine Regulations, 2002

Act:

Product Safety Act (Cap. 427)

Transposes:

Council Directive 84/539/EEC of 17th September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in veterinary medicine.

Link to Directive:

http://eurlex.europa.eu/LexUriServ/site/en/consleg/1984/L/01984L0539-20030605-en.pdf

Entry into Force:

1st July 2002

Publication:

Government Gazette of Malta No. 17,229 of 19th April 2002

Applies to:

Diagnostic and therapeutic electronic equipment used in veterinary medicine such as ECGs, thermoscanners, audiometers and drilling equipment.

Aim of Regulation:

To ensure that electro-medical equipment used in veterinary medicine meets a high and clearly-defined degree of safety both for the users of such equipment and for those receiving treatment by means of the equipment.

Amends:

Not applicable

Repeals:

Not applicable

 

In Vitro Diagnostic Medical Devices

Legal Notice 61 of 2002 (as amended)

Title:

In Vitro Diagnostic Medical Devices Regulations, 2002

Act:

Product Safety Act (Cap. 427)

Transposes:

Directive 98/79/EC of the European Parliament and of the Council of 27th October 1998 on in vitro diagnostic medical devices

Link to Directive:

http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998L0079:EN:HTML

Entry into Force:

1st January 2003

Publication:

Government Gazette of Malta No. 17,217 of 12th March 2002

Applies to:

Devices used in vitro for the examination of a specimen derived from the human body, including reagents, instruments and specimen receptacles.

Aim of Regulation:

A harmonized European law ensuring that in each Member State, in vitro diagnostic medical devices give patients, users and other persons a high level of protection and achieve the intended level of performance and ensuring free movement of such devices within the European Union.

Amends:

Not applicable

Repeals:

Not applicable

 

Medical Devices

Legal Notice 47 of 2003 (as amended)

Title:

Medical Devices Regulations, 2003

Act:

Product Safety Act (Cap. 427)

Transposes:

Council Directive 93/42/EEC of 14th June 1993 on the approximation of the laws of the Member States relating to medical devices.

Link to Directive:

http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML

Entry into Force:

31st January 2003

Publication:

Government Gazette of Malta No. 17,349 of 31st January 2003

Applies to:

Medical Devices and their accessories such as first aid bandages, X-ray equipment, heart valves, spectacles, dental materials catheters and solutions for cleaning or rinsing contact lenses.

Aim of Regulation:

A harmonized European law ensuring an equally high level of safety and health protection of patients, users and other persons with regard to the use of medical devices across the European Union and ensuring free movement of such devices within the internal market.

Amends:

Not applicable

Repeals:

Medical Devices Regulations, 2001 (LN 67 of 2001)

 

Consultations

In this section you can download closed and ongoing consultations issued by the regulatory team within the Malta Standards Authority. The ongoing consultations are available for you to respond to.  This section may also contain a list of upcoming consultations planned by the regulatory team.

You are kindly invited to submit comments relating to the ongoing consultations by the stipulated deadlines via consultations@msa.org.mt

 
Consultations:

 

MEDICAL DEVICES – Useful Links

 

  1. European Commission - http://ec.europa.eu/enterprise/medical_devices/index_en.htm
  2. European Commission guidelines related to medical devices - http://ec.europa.eu/enterprise/medical_devices/meddev/index.htm
  3. EU National Competent Authorities - http://ec.europa.eu/enterprise/medical_devices/ca/list_ca.htm

List of Harmonised Standards:

  1. Directive 90/385/EEC (last updated August 2007) - http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/c_186/c_18620070809en00550058.pdf
  2. Directive 93/42/EEC (last updated August 2007) - http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/c_186/c_18620070809en00400054.pdf
  3. Directive 98/79/EC (last updated August 2007) - http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/c_186/c_18620070809en00370039.pdf

Designated Notified Bodies:

  1. For Directive 90/385/EEC (active implantable devices) - http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=8&type_dir=NO%20CPD&pro_id=99999&prc_id=99999&ann_id=99999&prc_anx=99999
  2. For Directive 93/42/EEC (general medical devices) - http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13&type_dir=NO%20CPD&pro_id=99999&prc_id=99999&ann_id=99999&prc_anx=99999
  3. For Directive 98/79/EC (in vitro diagnostic devices) - http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=20&type_dir=NO%20CPD&pro_id=99999&prc_id=99999&ann_id=99999&prc_anx=99999

European Trade Federations:

  1. European Confederation of Medical Devices Associations (EUCOMED) - http://www.eucomed.be/
  2. European Diagnostic Manufacturers Association (EDMA) - http://www.edma-ivd.be/
  3. European Coordination of the Radiological and Electromedical Industry (COCIR) -  http://www.cocir.org/index.php?mode=0
  4. European Hearing Instrument Manufacturer Association (EHIMA) – http://www.ehima.com/
  5. Medical Technology (EUROM VI) – http://www.spectaris.de/english/branche/eurom6.htm
  6. Federation of European Dental Industry (FIDE) - http://www.fide-online.org/
  7. Federation of European and International Dental Technician Laboratory Owners (FEPPD) - http://www.feppd.org/

 

 

 

 

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