TRTA II provides assistance to Surgical Equipment, Gloves and Fan Manufacturers to go for CE Marking

Mr. Khawaja Muhammad Yousuf, CEO of National Productivity Organization giving his remarks at the certificate distribution ceremony in Gujrat
Mr. Adam Pinney, TRTA II International Expert during a training session on CE Marking in Sialkot

The intent of the TRTA II programme CE marking initiative taken is to prepare and implement a set of procedure allowing potential manufacturers wishing to export particularly to the EU countries to obtain the CE marking, as a necessary prerequisite for export, of their products. The programme intends, via manufacturers having CE marking, to give these manufacturers access to the EU market, although this TRTA II intervention is not specifically for increasing exports to the EU, initially the programme will deploy a trade expert to assist manufacturers to establish contact with importers and distributors in Europe in the selected manufacturing sectors.

 Nonetheless, obtaining CE marking, as a matter of principle, is not a goal in itself but is clearly intended to achieve exports and therefore profitability for manufacturers. In this connection, Dr. Adam Pinney, EU/UNIDO CE marking expert, conducted two 2-day training seminars, the first for medical devices (surgical instruments) and personal protective equipment (protective gloves) in Sialkot. The first seminar attracted 43 participants including 28 surgical instrument manufacturers and 6 glove manufacturers. The remaining nominees from Pakistan Gloves Manufacturers and Exporters Association, the Surgical Instruments Manufacturers Association of Pakistan were also amongst the participants. The representatives from Pakistan Standards and Quality Control Authority (from which three organisational Expert Trainers are likely to be selected), the Pakistan Council of Scientific and Industrial Research and Notified Bodies operating in Pakistan, were also trained. The training covered:

•  The benefits of free trade and a single market,

Mr. Khawaja Muhammad Yousuf, CEO of National Productivity Organization giving his remarks at the certificate distribution ceremony in Gujrat
•  History of the New Approach Directives and general principles along with;
•  Introduction to the directives on Medical Devices and Personal Protective Equipment (PPE);
•  Classification and attestation of conformity and ;
•  Roles and responsibilities under the directives,
•  Standards available for surgical instruments and protective gloves,
•  Technical file, manufacturer’s declaration of conformity and CE marking,
•  Application of the PPE by manufacturers (as an example).

Two practical exercises included were: which ERs from the directives applies to gloves and surgical instruments and developing a plan to obtain CE marking for gloves and; surgical instruments.

 Participants got intrinsically involved in training as was evident from the inquisitive queries raised during the session on issues such as reasons for non-acceptance of international standards and that if it is practical for manufacturers to seek certificates from material / component suppliers to avoid having to test for dangerous substances.

Mr. Khawar Rafiq, Ex-Chairman PEFMA addressing the training participants at the certificate distribution ceremony in Gujrat

The 2nd training was for the electric fans industry and was held at  Gujrat. This attracted 35 participants on the first day and 38 on the second day, of which 25 participants were from manufacturers, showing their keenness and interest into CE marking, representatives from the Pakistan Electric Fan Manufacturers Association and the Pakistan Standards and Quality Control Authority (from which two organisational Expert Trainers are likely to be selected), the Pakistan Council of Scientific and Industrial Research, Notified Bodies operating in Pakistan and a few independent consultants were also present. This training workshop addressed:

•  The benefits of free trade and a single market,
•  History of the New Approach Directives and general principles; introduction to the Low Voltage Directive (LVD); other regulatory and voluntary provisions applying to fans and roles and responsibilities under the LVD,
•  Standards available for fans; application of the LVD by manufacturers (as an example) and technical file, manufacturer’s declaration of conformity and CE marking.

Two practical exercises were also included: which Energy Reduction Systems (ERS) from the LVD and the Machinery Directive apply to fans, and developing a plan to obtain CE marking for fans. The results of these practical exercise indicated a good level of understanding of the overall procedure of CE marking.

The loud and clear message from workshops was that manufacturers need to be aware that they are responsible for the conformity of their products, rather than giving this responsibility to a certification body.

Certificate distribution ceremony at Gujrat