Article 120
On 26 May 2021, the Medical Device Regulation (EU) 2017/745 (MDR) began to apply following a 4-year transition period from the previous Active Implantable Medical Device Directive 90/385/EEC (AIMDD) and Medical Device Directive 93/42/EEC (MDD). The ‘Transitional Provisions’ within Article 120 of the MDR govern this switch and lay out specific derogations from the Regulation ...
General Obligations of Manufacturers (Article 10)
The EU Medical Device Regulation 2017/745 (MDR) and In-Vitro Diagnostic Regulation 2017/746 (IVDR) lay out what are known as the ‘General Obligations of Manufacturers’ in Article 10. The 16 paragraphs of this Article encompass the main requirements for compliance with the EU Regulations, from a manufacturer’s perspective, and are a good starting point to understanding ...
Unique Device Identifier
EU Unique Device Identifier (UDI) Both the EU Medical Device Regulation 2017/745 (MDR) and the EU IVD Regulation 2017/746 (IVDR) now require that all devices being placed on the market in accordance with these Regulations will need to be assigned a Unique Device Identifier (UDI) in order to facilitate product identification and traceability on the ...
EU Basic UDI-DI
In accordance with the new EU Regulations, the Medical Device Regulation 2017/745 (MDR) and the EU IVD Regulation 2017/746 (IVDR), manufacturers must assign a Basic UDI-DI (BUDI) to each of their devices (apart from custom-made devices). The Basic UDI-DI is an alphanumeric code assigned by the manufacturer which indicates a particular device group and is ...
European Medical Device Nomenclature (EMDN)
Since 1991 Medical Device experts from around the world (regulators, healthcare providers and manufacturers) have worked together to create the Global Medical Device Nomenclature (GMDN). This work was requested by the inter-governmental body, the Global Harmonisation Task Force (GHTF) to help accelerate international medical device regulatory harmonization and convergence. The GHTF has now been superseded ...
Person Responsible for Regulatory Compliance (PRRC)
Article 15 of both the in vitro diagnostic medical device regulation (2017/746) and the medical device regulation (2017/745) describe the new obligation that manufacturers and authorised representatives must meet such that they must have at least one Person Responsible for Regulatory Compliance (PRRC) “available within their organisation”. Manufacturers and authorised representatives must demonstrate that the ...
New MDR & IVDR Regulations
We imagine all manufacturers, and in fact almost anyone involved with medical devices, will now be aware of the arrival of the big regulatory changes in Europe. The original EU Medical Device Directive (MDD), IVD Directive (IVDD) and Active Implantable Medical Device Directive (AIMDD) have been deemed as being out of date and no longer ...
Certificates of Free Sale
For the purpose of exporting to countries outside the European Union (EU) a manufacturer may be asked to provide a Certificate of Free Sale (CFS) as evidence that their devices are CE Marked and available throughout the EU. There are many non-EU/EEA countries that require, as supporting documents for local market authorisation, a CFS issued ...
Person Responsible for Regulatory Compliance
The Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices and IVDs present a new obligation for manufacturers and EU Authorised Representatives to appoint at least one Person Responsible for Regulatory Compliance (PRRC). Article 15 of both these Regulations provides a detailed description of the qualifications the PRRC must have and their minimum responsibilities. The ...
Cybersecurity
Cybersecurity is an important aspect of any medical device which incorporates software. Such devices can be vulnerable to various cybersecurity threats, resulting in health-related, privacy, economic and reputational risks. As the medical device industry is gravitating more towards digital healthcare applications, the risk of cybersecurity attacks is on the rise and as such there is ...
