The Implementing Regulation (EU) 2021/2078 of November 26th, 2021, published on the Official Journal of the European Union, lays down application [...]
In October 2021, the Medical Device Coordination Group (MDCG) published the “Joint implementation and preparedness Plan for Regulation on in vitro [...]
In the past few weeks, the Australian Regulatory Authority - the Australian Therapeutic Goods Administration (TGA) – has published some guidelines [...]
If you are a Manufacturer of Medical Devices with a valid certificate issued by a Notified Body under Directive 90/385/EEC (AIMDD) or Directive [...]
If you are a Manufacturer of Medical Devices with a valid certificate issued by a Notified Body under Directive 90/385/EEC (AIMDD) [...]
Since Switzerland is a Third Country, there is no CE certificate which is valid in Switzerland, that is to say that [...]
As of May 26, 2021, Switzerland has fully-fledged become a Third Country (Swiss Exit) and Swiss Manufacturers are treated as any [...]
Starting from May 26, 2021, in accordance with the full application of MDR (EU) 2017/745 Regulation on Medical Devices and in [...]
The designation of the Swiss Authorised Representative (CH REP) is required to market all Medical Devices, including legacy devices, i.e. devices [...]
According to Medical Devices Ordinance (MedDO) Article 104a, several transitional periods for the nominee of the Swiss Authorised Representative CH REP [...]
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Thema Corp
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