Malaysia recognizes CE marked devices by permitting medical device registration via an abridged evaluation instead of a full conformity assessment. With the stringent new EU Medical Device and In Vitro Diagnostics Regulations, what will happen to existing approved registrations in Malaysia when the notified body in Europe and EC Certifications are no longer valid?
The Notified Bodies in Europe and the Conformity Assessment Body in Malaysia assess the conformity of medical devices before they are placed in the market for public or professional use. Comparing these two bodies may not be a straightforward ‘apple to apple’ comparison due to differences in the scope of their work. However, it is worth understanding their similarities and differences on the regulatory platform.
What are they and what do they do?
A Notified Body in Europe is an organisation that has been designated by an EU member state, EC (European Community) and functions to assess the conformance of a medical device according to EU legislation. After several assessments have been completed on products and manufacturers, the Notified Body will permit manufacturers to place CE marks on their products and subsequently allow them to be marketed anywhere in Europe.
A Conformity Assessment Body is a body appointed by the Malaysia Medical Device Authority to perform two types of assessment on products: abridged assessments or full conformity assessments. The former is for devices that have already obtained approvals from recognised countries such as Europe (CE mark), the US FDA, Health Canada, TGA Australia or the Japan MHLW. The latter follows a similar process to obtaining a CE mark in Europe and is more thorough and lengthy in scrutinising reports and documentation. The updated list of registered Conformity Assessment Bodies with the Malaysia Medical Device Authority can be found on the Malaysia Medical Device Authority website.
The Dependency on an EU Notified Body
CE marks granted by a Notified Body in Europe (EC) are a good benchmark for many developing countries to allow the CE-marked products to be placed in their market, as there is a level of confidence in the safety and effectiveness of the devices. The same scenario is applied in Malaysia as the authority recognizes CE-marked devices by permitting registration via an abridged evaluation instead of a full conformity assessment. The Conformity Assessment Body assesses the device in accordance with the validity of the Notified Body via the NANDO database, validity of certification, and a few other requirements. In the case where certification by an Notified Body in Europe is no longer valid, the Conformity Assessment Body in Malaysia is unable to grant certification for the device for product registration purposes, unless the device has other approvals, for example, by the the US FDA, TGA Australia, Health Canada or the Japan MHLW. This situation portrays the clear dependency of the Conformity Assessment Body in Malaysia on Notified Bodies in Europe.
Europe is an established medical device market with manufacturers commonly wanting CE marks on their devices. However, the Notified Body system has been constantly criticized for its lack of uniformity in certification procedures, varying levels of expertise across the Notified Bodies, and the questionable assessment of Notified Bodies on silicone gel breast implants in early 2010, which led to fears of a massive health disaster. This has prompted the publication of new Medical Device Regulations with stricter requirements on the surveillance of Notified Bodies in Europe. The new EU Medical Device Regulations and In-Vitro Diagnostics Regulations come into force at the end of May 2017, with full implementation taking effect by May 2020 and May 2022, respectively. Our previous post included the regulations for your reference.
Clearly, there will be a direct impact on product registration in Malaysia. Currently, the number of Notified Bodies in Europe is only declining and the trend is expected to persist, due to the tougher requirements imposed by the EU Commission. Apart from some changes to medical device requirements, the IVD regulations witnessed a much greater change as the regulations are likely to result in 80% of IVDs requiring a conformity assessment by a Notified Body compared with only 20% requiring conformity assessments within the previous directives.
As of today, the Malaysia Medical Device Authority had not made any announcement or notification regarding any change to the conformity assessment process in Malaysia. The circular letter No. 2 year 2014 revision 2 , which became effective on the 20th January 2017 still refers to the EU Medical Device Directive. According to this circular letter, only IVD devices that fall under Annex III, with an EC declaration of conformity (Section 1 to 5 of Annex III), which is applicable to only Class B IVD medical devices in accordance with Medical Device Regulations 2012, can be assessed via abridged evaluation. With the new EU regulations, this type of device may require conformity assessment in the EU instead of self-declaration by the manufacturer only, therefore the declaration of conformity alone is no longer sufficient for a manufacturer to comply and place a device in the market. So, does this mean that the approved registration in Malaysia that solely depends on the manufacturer’s declaration conformity is invalid? What are the actions to be taken by the Malaysia Medical Device Authority to address the gap associated with the change in Europe’s medical device regulations that clearly has an impact on Malaysian registrations too? Whatever happens, we hoped for a staggered implementation so that the industry can anticipate the change and have a manufacturing and marketing strategy in place to cater to any changes accordingly.