Certification requirements for personal protective equipment: Experts discuss with Indian manufacturers

The availability of safe personal protective equipment (PPE) is essential - especially in times of a pandemic. The global PPE market has expanded sharply in the past months and India is becoming an increasingly significant manufacturer. The Indian PPE industry has grown from zero to a EUR 780 million market since March. With export bans lifted, Indian manufacturers are now looking to sell their products also abroad.

To place PPE on the international market, manufacturers must comply with the relevant legislative safety requirements. On 8 December 2020, nearly 100 Indian and German experts and industry representatives discussed certification requirements for the European market as well as the applicable safety and quality aspects in India. The online exchange was jointly organised by the Global Project Quality Infrastructure (GPQI) and the Bureau of Indian Standards (BIS).

What is the CE marking and why is it important?

In his welcome remarks, Khushwant Singh from the India component of GPQI emphasised how well-functioning and internationally coherent quality infrastructures help in ensuring the access and availability to medical devices and PPE during the pandemic. Joint Secretary Nihar Ranjan Dash from the Ministry of Textiles highlighted the dynamic development of the Indian PPE industry, driven mainly by MSMEs. He underlined the relevance of safety and quality aspects for PPE and appreciated the Indo-German cooperation on this topic. Europe is one of the key export markets for Indian PPE manufacturers. Understanding the requirements and responsibilities of economic operators on the European market is therefore crucial, K. Veluchamy from the Indian Textiles Committee said.

The online exchange provided an opportunity for Indian manufacturers and procurement bodies to discuss these topics with experts from the Central Authority of the German Federal States for Safety (ZLS) and TÜV Rheinland. The director of ZLS, Hans-Georg Niedermeyer, presented key pillars of product safety in the EU. He elaborated that the sole responsibility for the conformity of their products lies with the manufacturers. The CE marking is attached by manufacturers as a statement of compliance with all relevant pieces of EU legislation. It serves as a kind of passport for the product to move freely on the EU market. It is checked by market surveillance authorities, who serve as the public control element in the European system.

Christiane Reckter from TÜV Rheinland outlined the requirements and testing procedures of PPE in line with the European PPE regulation. Together with her colleagues Pia Kathöfer and Charan Singh she answered various questions on the conformity assessment procedures for PPE, the involvement of notified bodies and the requirements for the technical documentation.

In India, BIS has developed standards and offers certification for certain product groups of PPE. J.K. Gupta from the Textile Department at BIS provided an overview of the Indian safety and quality requirements and answered questions on Indian regulations and procedures.

Next Steps in Indo-German Cooperation

PPE is one of the newer topics covered as part of the cooperation on medical devices and equipment within the Indo-German Working Group on Quality Infrastructure. The objective is to support Indian manufacturers by enhancing their understanding of the European system of product safety, for example the CE marking and the responsibilities of the economic operators, and the requirements for PPE on the European market.

As a next step in this cooperation, GPQI is developing a short practical guideline which summarises the key points discussed at the exchange and provides orientation on the CE marking of PPE for manufacturers, users and procurement bodies.

Click here to find out more about the Global Project Quality Infrastructure of the Federal Ministry for Economic Affairs and Energy (BMWi) and the activities of the Indo-German Working Group on Quality Infrastructure.