With our network of experts in SMEs and Regulatory experts from TSQ & E, TSQ Asia offer sustenance to businesses in diverse arenas for all diverse types of devices going through the challenge presented by new MDR.
Medical devices are devices and equipment for in vitro tests utilized either in hospitals by healthcare personals or directly used by the patients. There are more than five hundred thousand kinds of devices for in vitro tests and other devices on the European market alone. These ranges from an extensive variety of devices from home-based objects for instance pregnancy tests, sticking plasters, pacemakers, contact lenses to advanced devices like hip replacements, x-ray machines, breast implants, and blood tests.
- On 5 April 2017, two new Regulations on medical devices industry have been proposed. TSQ & E Asia has readopted as per those regulations. These substitute the prevalent medical device Directives. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, modifying Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and revoking Council Directives 93/42/EEC and 90/385/EEC
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
- MDR – Three years after entry into force for the Regulation on medical devices, but delayed due to COVID-19 (spring 2021)
- IVDR – Five years after entry into force, but delayed due to COVID-19 (spring 2023) for the Regulation on in vitro diagnostic medical devices.
MDR Time line
- April 5, 2017
The EU Medical Device Regulation was initiated.
- May 5, 2017:
The Regulation was incorporated in the Official Journal of the European Union.
- May 26, 2017
- The Regulation came into force and will apply in parallel with the current medical devices directive MDD 93/42/EEC for a transition period of three years.
- December, 2017
- The process of re-designating Europe’s Notified Bodies under the new regulation begins. The first designations are expected to be finalized some 12 to 18 months from the date of publication of the legislation May 25, 2020:
The transition period will then terminate and the Medical Devices Regulation will then be mandatory.