New MDR NB & UK MHRA Guidance & QMS Remote Audits

SGS FIMKO OY has joined the list of certification bodies notified under the Regulation (EU) 2017/745 on medical devices and displayed on the NANDO website (18 MDR Notified Bodies at the moment):

Takomotie 8
Country : Finland

Phone : +358 9 696 361
Fax : –

Email :
Website :

Notified Body number : 0598 (ex-0403)

The scope of designation covers different product ranges, in many cases limited up to Class IIb devices (the list below is not exhaustive):

2. Active non-implantable devices for imaging,monitoring and/or diagnosis

– MDA 0201 Active non-implantable imaging device utilising ionizing radiation

– MDA 0203 Active non-implantable devices for monitoring of vital physiological parameter

2. Non-active non-implantable devices

– MDN 1205 Non-active non-implantable orthopaedic and rehabilitation device

– MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable device

MDS 1007 Devices incorporating or consisting of nanomaterial

The European Commission has opened the possibility to perform remote audits related to the Quality Management System (QMS) under the EU MDR & IVDR! In its recent Notice, the Commission nevertheless conditions it on a cumulative set of circumstances to be considered:


the exceptional and unforeseen circumstances caused by the COVID-19 crisis;


the need to ensure continuous availability of safe and performant medical devices and in vitro diagnostic medical devices, and to help prevent the risk of shortages of such devices within the EU in the interest of public health, especially when devices are clinically necessary during the period of COVID-19 restrictions;


compliance with the requirement for on-site audits in the medical devices Regulations generally serves to verify conformity with regard to manufacturing and other relevant on-site processes. Although, at this time, it has not been possible to fully quantify the impact of the need referred to in point 2 above, information at the disposal of the Commission on notified bodies’ use of extraordinary measures, including remote audits, related to assessments performed under the medical devices Directives (3) appears to demonstrate an adequate level of safety and not to compromise the overall reliability of such assessments. This is provided that these measures are taken only following an objective case-by-case analysis of each individual situation in light of the relevant circumstances, including travel restrictions and national orders, to identify if there are concrete obstacles, which would prevent the taking place of a safe on-site audit and where the inability to carry out such an on-site audit could prevent granting access or ensuring continued supply of devices to the market.

The UK Competent Authority MHRA also published a relevant Guidance for retailers: supplying medical devices to Northern Ireland, where it reminds that:

”From 26 May 2021 the new EU Medical Device Regulators (MDR) (Regulation 2017/745) will fully apply in Northern Ireland. This will cover medical devices, including for example, bandages, plasters and thermometers.


From 26 May 2022, the new in vitro Diagnostic Medical Devices Regulations (IVDR) (Regulation 2017/746) will fully apply in Northern Ireland. This will cover in vitro diagnostic medical devices, including for example pregnancy self-test kits.”

The MHRA also emphasizes that under the MDR & IVDR, importers have additional obligations than under the current regulatory framework!

Have a look at our MDlaw template to facilitate in your compliance throughout your supply chain.

Finally, we would like to inform you of the new Guidance published by the MHRA related to the IVDs in the post-Brexit scenario. This is an important document for those manufacturers selling their IVDs on the market of Great Britain after 1 January 2021.

You can find all the mentioned Guidance documents in our Library of documents – UK & Switzerland.


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