Our February MedTech roundup covers news from Swiss Medtech regarding a pioneering data exchange platform, updates from the MDCG on IVD classification rules and MDR vigilance requirements, and the latest information from the FDA on UDI, software algorithm device classification, SLA laser products, and premarket approvals. Read on for more…
Data exchange made easy with firstbase healthcare
The “firstbase healthcare” data exchange platform provides a central database on which to record medical device master data and handles data transfer to all relevant official databases spanning EUDAMED, GUDID, and Swissdamed, as well as Swiss hospitals, clinics, laboratories, and distributors.
Over recent months, various renowned Swiss hospitals and MedTech companies have closely collaborated to help develop the platform. On 28 February 2023 at noon, Swiss Medtech will host a webinar presented by the platform’s creators, GS1 Switzerland, where the functionality of firstbase healthcare will be shared and explained.
You can find out more about firstbase here, and how to join the webinar here.
MDCG updates guidance on classification rules for IVD medical devices under IVDR
MDCG 2020-16 rev.2 addresses the classification of in vitro diagnostic medical devices (IVDs) under IVDR, providing clarifications on the classification rules set out under Annex VIII.
The primary purpose of the document is to provide guidance to manufacturers, notified bodies, and health institutions on how to classify an IVD prior to placing it on the market, making it available on the market or putting it into service in the European Union. It’s also intended to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution.
Revision 2 of the guidance covers changes that affect rules 1, 2, and 3, and includes the addition of Annex 2. You can read the guidance here.
MDCG shares Q&A on vigilance terms and concepts outlined in MDR
MDCG 2023-3 aims to clarify important terms and concepts that are outlined in Section 2, Chapter VII of MDR, in order to establish a common understanding that will facilitate effective and harmonised implementation of the MDR vigilance requirements.
Aimed at competent authorities, economic operators and other relevant parties, the Q&A covers topics spanning incidents and serious incidents, user errors, undesirable side-effects, and field safety corrective actions.
Read the full questions and answers here.
EAAR conference updates industry on EU market state of play
Earlier this month, the 7th European Association of Authorised Representatives (EAAR) Annual Conference on New Medical Device Regulations took place in Brussels.
The two-day conference saw a host of industry professionals such as Medtech Europe, the EU Commission, and the UK’s MHRA deliver useful insights into the current state of play in the EU market, and what’s expected of the EU Commission regarding the tackling of medical device shortages.
The amendment to MDR and IVDR transition timeframes was a particularly hot topic, with Medtech Europe and the EU Commission sharing that the council has given the green light to send the document to European Parliament without any changes. It’s expected that the amendment will be published in the Official Journal of the EU in mid-spring this year.
Find out more here about the topics covered in the conference, which also include MDR and IVDR best practices.
FDA revises information collection regarding UDI
The FDA has submitted information to the Office of Management and Budget (OMB) for review regarding medical device labelling requirements and Unique Device Identification (UDI).
For operational efficiency, the agency is revising the information collection to include burden that may be attributable to activities found in 21 CFR part 830, currently approved in OMB control number 0910-0720 and established through rulemaking on 24 September 2013 (0910-AG31).
You can submit written comments and recommendations on the collection of information until 16 March this year. Find out more here.
FDA classifies software algorithm device as Class II
The FDA has classified the software algorithm device to assist users in digital pathology into Class II (special controls). Effective since 2 February this year, the order includes the special controls that apply to the device type which will be part of the codified language for the software algorithm device to assist users in digital pathology’s classification.
FDA issues final guidance on SLA laser products
The FDA has issued final guidance that outlines their approach regarding the applicability of their performance standard regulations to surveying, levelling, and alignment (SLA) laser products. The document covers what an SLA laser product is, examples of SLA and non-SLA laser products, and information on variances and exemptions from SLA laser product class limits.
You can access the final guidance here.
FDA revises information collection on premarket approval of medical devices
The FDA is revising their information collection regarding the premarket approval of medical devices, to include burden that may be associated with recommendations found in the FDA guidance: “Providing Information about Pediatric Uses of Medical Devices” (May 2014), currently approved in OMB control number 0910-0748.
You can submit comments on the collection of information until 31 March this year, via written submission or electronically. Find out more here.
That concludes our February 2023 MedTech news roundup. Check back in March for more medical device news and updates.
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