EUROPEAN UNION (EU)
Updated guidance on significant changes under MDR | 12 May 2023
The guidance document MDCG 2020-3 Rev.1 is intended to clarify the concept of ‘significant changes in the design and intended purpose’ under Article 120(3c), point (b) MDR. It concerns manufacturers of legacy devices.
This guidance document does not elaborate on the process for manufacturers’ submission and notified bodies’ assessment of changes to the approved design or substantial changes to the approved quality system or the product range covered.
Commission guidance on content and structure of summary of clinical investigation report | 08 May 2023
The document is intended to provide Commission guidance, following Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereafter: the MDR), for the content and structure of the summary of the clinical investigation report.
The guidance aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis and results of the clinical investigation in terms and in a format that is easily understandable to the intended user of the medical device.
UNITED KINGDOM (UK)
New regulatory pathway for innovative medical technologies | 26 May 2023
Plans are advancing for a new regulatory pathway that facilitates the development of innovative technologies by providing innovators and manufacturers with a multi-partner support service, including targeted scientific advice that brings new products to patients sooner. The Innovative Devices Access Pathway (IDAP), set for launch later in 2023, will be operated by the Medicines and Healthcare Products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), Health Technology Wales (HTW) and Scottish Health Technology Group (SHTG). Innovators of medical technology (commercial or non-commercial, UK based or international) that address clinical needs are encouraged to register for further information before a planned 2023 pilot launch. Please send an email with details to [email protected].
Regulatory status of equipment to prevent COVID-19 | 17 May 2023
Different regulations apply to devices and equipment including hand gels, face masks and coverings and PPE (personal protective equipment). The latest MHRA guidance helps manufacturers of equipment that are used to prevent COVID-19 to choose the right regulatory pathway to market the product in the Great Britain market.
MHRA guidance on Medical Device regulation and enforcement | 17 May 2023
MHRA is responsible for checking that medical devices in the UK comply with legal requirements.
This guidance includes:
- Contact details to report a non-compliant medical device
- Information on MHRA’s enforcement duties after receiving a complaint
- MHRA’s routine monitoring role
- the manufacturer’s rights if they have received an enforcement notice
The government intends to extend acceptance of CE-marked devices in Great Britain beyond 30 June 2023. For more detail on this, visit the implementation update page. The guidance also contains crucial information on reporting non-compliant medical devices to MHRA.
MHRA guidance on Off-label use of medical devices | 17 May 2023
The latest MHRA guidance on off-label use was released on 17th May 2023. Medical devices should be used as described by the manufacturer in the instructions. If the device is used in any other way, it’s considered ‘off-label’ use.
Off-label use of a device could lead to dangers including:
- Adverse reactions
- Inadequate sterilisation
- Insufficient mechanical strength and/or structural integrity
- Insufficient durability
- Misuse due to lack of adequate training for the device
The guidance contains some common examples of problems with off-label use.
MHRA guidance on Class I medical devices | 17 May 2023
This updated guidance applies to manufacturers of Class I medical devices, including accessories but excludes devices intended for clinical investigation and custom-made devices. The guidance covers crucial topics such as UKCA marking, technical documentation for Class I medical devices, clinical evaluation and post-market requirements.
MHRA guidance on legal requirements for prosthetic, orthotic and ophthalmic devices | 17 May 2023
MHRA has updated its guidance on legal requirements for prosthetic, orthotic and ophthalmic devices. The guidance includes information on the following aspects:
- Custom-made prosthetic, orthotic and ophthalmic devices
- Registration of devices in the UK
MHRA guidance on DEHP phthalates in medical devices | 17 May 2023
The latest MHRA guidance on DEHP phthalates in medical devices, released on 17th May, describes the safe use of phthalates in medical devices. Phthalates are chemicals added to polyvinyl chloride (PVC) plastic to make it softer and more flexible. Di (2-ethylhexyl) phthalate (DEHP) is the type used the most in medical devices such as:
- Intravenous (IV) tubing
- Umbilical artery catheters
- Blood bags and infusion tubing
- Enteral nutrition feeding bags
- Nasogastric tubes
MHRA guidance on software applications medical devices | 17 May 2023
This updated guidance applies to software applications considered to be medical devices and how they are regulated. The guidance is now updated with Medical device stand-alone software, including apps’ with the implementation of new regulations, updates to various links, including MORE and new software vigilance guidance. The guidance can be accessed here.
MHRA guidance on virtual manufacturing of medical device | 17 May 2023
MHRA has released an updated version of the guidance for manufacturers who don’t design or manufacture devices but place their names on the product. A “virtual manufacturer” is an organisation that fully sources its own named product from another company (sometimes known as the ‘original equipment manufacturer’), which has designed and manufactured an identical UKCA/CE/CE UKNI marked product. In practice there is no difference in the regulatory requirements applying to a manufacturer and a virtual manufacturer.
Extension of acceptance of CE marked devices in Great Britain | 01 May 2023
CE-marked medical devices are expected to be accepted in Great Britain for an extended period. A statutory instrument has been laid in Parliament, enabling an extended timeframe for acceptance of CE-marked medical devices on the Great Britain market.
Subject to Parliamentary approval, this will mean that CE-marked medical devices will be accepted on the Great Britain market beyond the current deadline of 30 June 2023.
Swiss guidelines on reprocessing in healthcare institutions | 20 May 2023
Update of the Swiss guideline based on SN EN ISO 17665, taking account of, and applying, the contents of SN EN 285. The requirements regarding reprocessing are set out in Article 72 of the Medical Devices Ordinance (MedDO). Medical devices intended for multiple use or single use that are not supplied in sterile condition must be reprocessed before use in accordance with the current state of technology and science, taking account of the manufacturer’s instructions and the requirements of good hygiene. The updated guidance can be accessed here.
Phase out of ISO 13485 certificates for IVD medical devices | 25 May 2023
The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices ends on 26 May 2023.
This means TGA can no longer accept ISO 13485 certificates to support IVD inclusion applications. Approved IVD medical devices supported by ISO 13485 certificates remain valid until the certificate expires. Sponsors will then need another form of acceptable manufacturer evidence to support their approved device. The other supported evidence for TGA inclusion can be accessed here.
EU MDR transition extension | 05 May 2023
The TGA recently implemented an EU MDR transition strategy for Australian medical device sponsors and stakeholders. More recently, the EU extended the transition, prompting the TGA to review its strategy and to review the impact on reclassification reforms underway in Australia.
UNITED STATES OF AMERICA (USA)
FDA guidance on Laparoscopic power morcellators | 25 May 2023
Laparoscopic power morcellators are Class II medical devices used during laparoscopic surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site (typically 2 cm long or less). The guidance document provides the FDA’s recommendations on non-clinical performance testing to support premarket submissions for gynecologic and general laparoscopic power morcellation containment systems and may also help manufacturers comply with the special controls related to non-clinical performance data for these devices. This guidance recommends non-clinical test methods that may help manufacturers meet the non-clinical performance data requirements identified in the special controls codified in 21 CFR 884.4050(b)(4) (for gynaecologic use) and 21 CFR 878.4825(b)(4) (for general use), and also includes other non-clinical testing recommendations to support a 510(k) submission/substantial equivalence determination.
MDSAP QMS Documents | 23 May 2023
The Medical Device Single Audit Program allows an MDSAP-recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. FDA has published MDSAP QMS documents and MDSAP QMS Procedures and Forms for the general public.
Consultation on proposed changes to the Medical Devices Regulations to address future public health emergencies | 23 May 2023
On the 22nd of February, 2023, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) came into force. These regulatory amendments resulted in the creation of Part 1.1 of the MDR. Part 1.1 is a permanent regulatory framework for COVID-19 medical devices.
Health Canada is proposing to expand the scope of Part 1.1 to:
- Apply to other medical conditions that result in significant risk to public health in Canada, and immediate action is required to deal with the risk
- Include medical devices for which there is a UPHN to diagnose, treat, mitigate or prevent these medical conditions