Medical device CE marking

COVID-19 Q&A

2021-02

The European Commission issued a Q&A on in vitro diagnostic medical device conformity
assessment and performance in the context of COVID-19.

The document can be found in our library.

Source: European Commission

EC guidance on legacy devices in EUDAMED

2021-02

The European Commission has published a document explaining how and when legacy devices will be identified in the new Eudamed medical device database. Legacy devices are products that have been CE marked in the context of the current medical device directives but not under the new Medical Device Regulation, nor the IVD Regulation.

The Management of Legacy Devices is a technical document, the majority of which consists of flowcharts and other tables, which explains how the different Unique Device Identifiers (UDIs) will be generated/assigned for legacy devices as part of registration.

The document can be downloaded in our library.

Source: European Commission

MHRA issued guidance 2.0 on applying human factors to medical devices

2021-02

MHRA has published an updated guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks. The updates are primarily around this guidance applying to Great Britain, changes in references to legislation and the introduction of the new UKCA mark.

The document can be downloaded in our library.

Source: MHRA

 

Guidance on clinical trials during COVID-19

2021-02

On February 4, the EC, EMA and HMA issued a new version (v4) of the Guidance on the management of clinical trials during the COVID-19 (Coronovirus) pandemic.

Key changes from v3 (April 27, 2020): remote source data verification.

The document can be downloaded in our library

Source: European Commission

New IVD symbols for compliance with the IVDR

2020-10

By 26 May 2022, IVD devices will transition to the new IVD Regulation EU 2017/746. This regulation will require devices intended for self-testing, devices intended for near-patient testing and certain rapid tests (not for self-testing and not for near patient testing) to state these facts on their labels.

The use of symbols on the label is an effective way of compliance and it is permitted by the IVDR. By including these symbols proposed by MedTech Europe, the intended user of your device will be clear. It will also remove the necessity to translate that indication into all EU languages.

The document can be downloaded in our library

Source: MedTech Europe

Common Specification for reprocessing of single use devices

2020-08

The European Commission has published the first common specifications under the MDR. It concerns reprocessing of single use devices.

Under MDR, single-use devices may be reprocessed where permitted by national law. Member states may also determine what rules they will apply to single-use devices reprocessed and used within a health institution, so long as the reprocessing is performed in accordance with the common specifications laid out in the regulation.

To ensure the quality of the reprocessing activities, CS concerning risk management should include minimum requirements for staff, premises and equipment.

Source: https://eur-lex.europa.eu/eli/reg_impl/2020/1207/oj

Consolidated MDR now available (2020-04-24)

2020-05

The consolidated MDR is now available on the European Commission website.

 

Amended by:

Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020

 

Corrected by:

Corrigendum, OJ L 117, 3.5.2019, p.  9 (2017/745)

Corrigendum, OJ L 334, 27.12.2019, p.  165 (2017/745)

 

The consolidated MDR can be downloaded in our library

Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20200424

Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices

2019-11

The European Commission has extended the call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices.

Interested candidates are invited to submit their application before 24 November 2019 through the following website:

https://ec.europa.eu/growth/content/call-expression-interest-expert-panels-medical-devices-and-vitro-diagnostic-medical-devices_en

An informative flyer you may find here: link

Designated Notified Bodies for MDR and IVDR

2019-11

At the moment there are 7 notified bodies designated to perform audits according the MDR. These notified bodies are: BSI-UK, BSI-NL, DARE!!, DEKRA Certification, IMQ and TÜV Rheinland, TÜV-SUD.

Under the IVDR, there are now 2 notified bodies designated. These notified bodies are: BSI-UK, DEKRA Certification.

We recommend staying in close contact with your Notified Body concerning their designation for the MDR and/or IVDR.

Source: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main