UK – Implementation of the future regulation of medical devices and extension of standstill...
On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom....
Europe – MDCG raises alarm over lack of MDR, IVDR applications
The European Commission’s Medical Device Coordination Group (MDCG) is telling medtech manufacturers to get certified under the new device and diagnostics regulations as soon...
Europe – Commission welcomes adoption by European Parliament of measures to improve the availability...
The Commission welcomes the adoption by the European Parliament today of measures, proposed by the Commission in January 2024, to improve the availability of in vitro diagnostics...
UK – Medical devices: UK approved bodies
Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
UK – Implementation of medical devices future regime
On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom....
Europe – Nouvel Organisme Notifié au titre du règlement (UE)2017/746
Nouvel Organisme Notifié au titre du règlement (UE)2017/746 :
National Standards Authority of Ireland (NSAI)...
Europe – MDCG 2022-21 Guidance on periodic safety update report (PSUR) according to regulation...
The Periodic Safety Update Report (PSUR) has been introduced in Article 86 of the Medical
Device Regulation (MDR) 2017/745. The introduction of the PSUR requirement...
Europe – MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical...
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if...
Europe – MDCG 2022-18 : Position Paper on the application of Article 97 MDR...
In accordance with Article 5 of Regulation (EU) 2017/745 on medical devices (MDR),
a device may be placed on the market only if it complies...
Switzerland – Switzerland, too, extends medical device certifications to safeguard supply
Switzerland plans to extend the certification of medical devices to match changes in the EU and reduce the risk of supply disruption.
Recently, the EU...
