The current MD market

No country in the world is completely self-sufficient with the complete range of Medical Devices (MDs). The MD market has been substantially growing in response to meet the growing populations and their need for MD to address health-related issues and critical medical requirements. The MD market covers a range of products – from the most basic syringes, thermometers etc., to highly advanced implantable devices, diagnostic & surgical equipment.

At one end of the spectrum exists the medical device manufacturing industry under the strict surveillance of regulatory bodies like EU & FDA in concurrence with the health regulations of the World Health Organization (WHO), while at the other end exists a rapidly evolving MD market conducted by its economic operators (namely manufacturers, importers and distributors) operating under various challenges.

According to a survey of medical device industry managers, the biggest challenge faced by almost 70% is the regulatory compliance requirements that affects the pre-market & post-market distribution across every country and continent. Since medical devices are both imported/exported across countries, it is essential to follow strict licensing regulations and import/export required for distribution, delivery, and sales of the devices through the supply chain.

Implementation of MDR and its implication

A health scare sparked by Poly-implant Prothèse (PIP) scandal was one of many events that triggered the EU Commission to review its decades-old Medical Device Directive (MDD) (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). New regulations, known as Medical Device Regulation (MDR) were drafted to implement a common approach, and replace varying country specific rules. Under the new regulations, stricter requirements will be imposed by Notified Bodies (NB), mandating them specific compliance requirements. A Notified Body (NB) is an organization designated by an EU country to assess the conformity of certain medical product according to procedures set out in the applicable legislation before it is placed on the market.

Most of the compliance focus under the old rules was centered on device manufacturers. The new rules, under the Medical Device Regulation (MDR), elevates the importance of importers, distributors and the supply chain through the entire life cycle of the device in EU market.

Deadline to comply with MDR

The MDR was officially published on May 05, 2017 and implemented on May 25, 2017. Currently, approved economic operators will have a transition time of 3 years until May 26, 2020 to meet the requirements of the MDR. While for few economic operators, the MDR will provide an additional time, allowing them to place new products on the market for a maximum of 4 more years after the date of application. For this extended transition period, additional requirements will apply.

Stay tuned for Part 2…