Introduction A new regulatory system for medical devices is being implemented in the European Union. The old Directives on medical devices are being replaced by a single Regulation on medical devices. Directives 93/42/EEC on medical devices (MDD)1 and 90/385/EEC on…
The European Commission has published five additional documents to support the implementation of the Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR): Factsheet for Authorities in non-EU/EEA States on Medical Devices and in vitro…
Introduction Time is running out to transition fully to the new European Union (EU) Medical Devices Regulation (MDR)1 and In Vitro Diagnostics Regulation (IVDR)2. With less than two years to comply for the MDR and four years for the IVDR,…
The UK Medicines and Healthcare products Regulatory Agency has produced a Guidance for products without an intended medical purpose (Annex XVI) under the new Medical Device Regulation (EU 2017/745)1. Annex XVI products are those for which a manufacturer claims only…
On 9 October 2018, the Commission published the latest version of its public rolling plan1 for implementation of the Medical Device Regulation and In Vitro Diagnostic Regulation. With the exception of an Implementing Act on the designation of one or…
The European Commission has published five new documents for manufacturers that relate to the implementation of the Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR): Factsheet for manufacturers of medical devices1; Implementation model: medical…
Five new, non-binding guidance documents concerning Unique Device Identification (UDI) have been adopted by the Medical Device Coordination Group (MDCG) in accordance with Regulation (EU) 745/2017 (the Medical Device Regulation, MDR) and published on the European Commission website1: MDCG 2018-3,…
Introduction The Medical Device Regulation (Regulation (EU) 2017/745), or MDR, entered into force on 26 May 2017 with a transitional period of three years. Therefore, manufacturers have less than two years left to fulfil and implement the enhanced requirements. A major component is…
Introduction Notified Bodies (NBs) are the entities responsible for assessing and granting certificates for the majority of medical devices and in vitro diagnostics (IVDs) placed and distributed in the European market and beyond. The new Medical Device Regulation (EU) 2017/745…
Six German industry associations have expressed their fear of a significant bottleneck in the Notified Body designation process and in the implementation of the new Medical Devices Regulation, with negative effects on the device industry and the healthcare market1. They…
Introduction In recent years, the number of combination products entering the global market has grown significantly due to advances in medical technology as well as an increase in user demand. While these products hold great promise for the future of…
Introduction On 5 May 2017, the new Regulation 2017/745 on medical devices (MDR) was enacted, with a full implementation date across the 28 European Union (EU) Member States set for 26 May 20201. On this day, the Regulation will replace…
Introduction The question of Authorised Representative (AR) liability has been a recurrent topic of conversation for manufacturers, lawyers and regulators.The argument is that as ARs are recognised as de facto manufacturers in situations where there is no manufacturer within the…
Swissmedic, the Swiss Agency for Therapeutic Products, has decided to follow the harmonised European approach for handling CE mark certifications of manufacturers affected by the de-designation of their Notified Bodies1. Like its counterpart in France, Swissmedic has established a period…
The formal adoptions of the new Regulations for medical devices and in vitro diagnostics (IVDs) are currently foreseen for the spring of 20171. They will be published in the Official Journal shortly thereafter, and enter into force on the 20th…
The European Parliament1 has formally endorsed the new Medical Devices Regulation (MDR)2 and the new In vitro Diagnostics Regulation (IVDR)3. The next step is for publication of the two Regulations in the Official Journal, which is expected to take place…
The reprocessing of single-use medical devices (SUDs) takes place worldwide, including, to varying levels, within European hospitals. Manufacturers, hospitals and commercial companies have historically been subject to different regulatory requirements but this will all change with the adoption of the…
On 5 May 2017, the long-awaited updates to the European legislative framework were finally published as Regulation (EU) 2017/745 on medical devices1 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDs)2. The Regulations came into force 20 days…
Introduction On 5 May 2017, Regulation (EU) 2017/745 on medical devices (MDR)1 and Regulation (EU) 2017/746 on in vitro diagnostics (IVDR)2 were finally published in the Official Journal of the European Union. The twoRegulations will enter into force in all Member…
Introduction In late 2012, the European Commission published its proposals for two new Regulations, one for medical devices and one for in vitro diagnostics (IVDs), to replace the current Directives which have been in place for over 25 years (Directive…
Introduction In May 2017, the Medical Devices Regulation and the In Vitro Diagnostics (IVD) Regulation ((EU) 2017/7451 and (EU) 2017/7462, respectively) came into force 20 days after their publication in the Official Journal. This marked the end of a very…
The Medicines and Healthcare products Regulatory Agency (MHRA) has published An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR)1. The Introductory Guide takes the form of an interactive pdf and has…
Introduction It is well recognised that the new Medical Device Regulation (EU) 2017/745 (MDR)1will have a significant impact on device manufacturers, Notified Bodies (NBs) and device Competent Authorities (CAs). However, it will also affect how the increasing number of drug/device…
1. Clinical evaluation and clinical investigations[medical devices] / Performance evaluation and performance studies [IVDs] 2. Scope and classification 3. Notified Bodies and conformity assessment 4. Post-market surveillance and vigilance for both medical devices and IVDs 5. Eudamed andUnique Device Identification…
A revision of the Medical Devices Ordinance (MepV) was adopted by the Swiss Federal Council on 25 October 2017 and covered all points arising from the new European Regulations on medical devices and in vitro diagnostics (IVDs) that applied from 26…
As a first step towards implementing the new European Regulations on medical devices and in vitro diagnostics (IVDs), Finland made some amendments to its Law on health care equipment and supplies on 20 December 20171. The amended Law clarifies Valvira’s position as…
The Transition Sub Group of the Competent Authorities for Medical Devices has published two frequently-asked-question (FAQ) documents: one on the Medical Device Regulation’s (MDR’s) transitional provisions1 and one on the In Vitro Diagnostic Regulation’s (IVDR’s) transitional provisions2. Each document addresses…
Introduction The new European Medical Devices Regulation (Regulation (EU) 2017/745, MDR)1 does not assign a specific legal status to three-dimensional (3D) printing and leaves unanswered the question of the applicable legislation in relation to this practice, which undoubtedly represents the…
A consultation is being held until 26 May 2018 on a Draft Act amending the Federal Law on Medicinal Products and Medical Devices (Law on Therapeutic Products, HMG)1. This partial revision of the HMG aligns the Swiss regulations for medical…
A reflection paper1 published in January 2018 responds to the increasing regulatory focus on quality, safety and performance aspects of devices integral to medicinal products, reflecting the growing complexity of some of these device components (e.g. auto-injectors, on-body pumps, and…
The Medical Device Coordination Group (MDCG) recently endorsed a description of the requirements for a future European medical device nomenclature1. According to Article 26 of Regulation 745/2017 on medical devices and Article 23 of Regulation 746/2017 on in vitro diagnostic…
