2022-07
The European Commission has adopted common specifications for several types of high-risk diagnostics, such as HIV tests and SARS-CoV-2 tests. The specifications set uniform and rigorous benchmarks for tests across the EU, clarifying the requirements for market actors and protecting EU patients.
The document can be downloaded in our library
Source: European Commission
2022-06
On June 29, 2022, the European Commission published the ‘Blue Guide on the implementation of the product rules 2022’. The Guide is meant for a better understanding of EU product rules and facilitation of their uniform application across sectors throughout the Single Market.
The product rules are aligned with the New Legislative Framework, which covers for instance toys, measuring instruments, radio equipment, low voltage electrical equipment, medical devices, fertilising products. The Blue Guide also provides explanations and advice regarding the European conformity assessment system, the accreditation of laboratories, the CE marking, and market surveillance.
The Blue Guide is a non-binding instrument and it was published in 2000. It has been subsequently updated twice, in 2014 and 2016. The current revision is a substantial update and takes into account developments that have come up since 2016, for example related to the Market Surveillance Regulation (EU) 2019/1020. It also elaborates on specific features such as distance sales, making products available on the market subject to physical modifications or software updates and the assessment of conformity assessment bodies. The guide is available in Irish for the first time.
The guide can be downloaded in our library
Source: European Commission
2022-06
This Position Paper concerns documents that assist stakeholders to implement the Medical Devices Regulation, 2017/745 (“MDR”) and the In Vitro Medical Devices Regulation, 2017/746 (“IVDR”). In order to assure market availability of safe and performing medical devices, this Position Paper lays out an industry view on expectations for the use and pragmatic timing of application of such documents.
The document can be downloaded in our library
Source: MedTech Europe
2022-05
The Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) set out requirements and responsibilities for operators in the medical devices supply chain. The information sheet outlines the roles and obligations of the Swiss authorised representative, the importer and the distributor.
The information sheet can be downloaded in our library
Source: Swissmedic
2022-05
This Q&A intends to clarify certain interfaces between the Regulation (EU) No 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It was developed by clinical trial experts from Clinical Trials Facilitation and Coordination Group (CTFG) and in vitro diagnostics experts from the IVD sub-group of the Medical Device Coordination Group (MDCG). It has been adopted by CTFG, the Clinical Trials Expert Group of the European Commission and endorsed by the MDCG.
The need for interoperability of databases for clinical trials with medicinal products and medical devices is laid down in the new Regulations, however, no further details on the interface of IVDR and CTR are in the legislation, e.g. the requirements for assays used in the context of clinical trials.
Assays used in clinical trials may range from CE marked in vitro diagnostic medical devices (IVDs) to trial- or medicinal product-specific assays that are not always meant to be developed as IVDs. The need to clarify requirements for these assays lead to the Q&A and the concept of the “medical purpose of an assay in a clinical trial” as a specific setting.
The document can be downloaded from our library
Source: European Commission
2022-05
Until now, Switzerland has been participating in the European Union internal market for in vitro diagnostic medical devices through the medical devices chapter of the EU-Switzerland Mutual Recognition Agreement (MRA). The medical devices chapter of the MRA has provided for recognition of conformity assessment certificates between the European Union and Switzerland based on equivalence of Directive 98/79/EC on in vitro diagnostic medical devices and the corresponding Swiss legislation. This has facilitated seamless trade of in vitro diagnostic medical devices between the parties.
The new Regulation (EU) 2017/746 on in vitro diagnostic medical devices has become applicable on 26 May 2022, replacing Directive 98/79/EC. In the absence of an update of the MRA to include Regulation (EU) 2017/746, the part of the MRA chapter covering in vitro diagnostic medical devices ceases to apply as of 26 May 2022.
As a result, the trade facilitating effects of the MRA for in vitro diagnostic medical devices, including the mutual recognition of conformity assessment results, the absence of the need for an authorized representative and the alignment of technical regulations, cease to apply as of that date.
The document can be downloaded from our library
Source: European Commission
2022-05
On May 20, 2022, the MDCG published 3 new documents:
Source: European Commission
2022-05
On May 4, 2022, the MDCG published the 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR.
This guidance document is intended to provide clarification on the concept of ‘significant changes in the design and intended purpose’ under IVDR Article 110(3). It concerns manufacturers of devices that are compliant with Directive 98/79/EC and that are placed on the market or put into service after 26 May 2022 during the transition period in accordance with Article 110(3) IVDR, irrespective of whether or not those devices required notified body involvement under the IVDD.
The document can be downloaded in our library
Source: European Commission
2022-04
On April 1st, 2022, the MDCG published an updated Joint Implementation Plan on the IVDR. This updated plan on actions is considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDR
The document can be downloaded in our library
Source: European Commission
2022-03
On March 24, the MDCG published revision 1 of the 2019-9 document: Summary of safety and clinical performance: A guide for manufacturers and notified bodies.
The MDR requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than custom-made or investigational devices. The SSCP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed).
The main purpose of this document is to provide guidance on the presentation, content and validation of the SSCP. The word “shall” is used when there is a corresponding “shall” in the MDR, otherwise “should” or “recommended” etc. is used indicating the interpretation of the MDR.
The document can be downloaded in our library.
Source: European Commission
