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UKCA: UK’s Proposed ‘CE Mark’ Replacement

In February 2019, the MHRA published guidance on the use of the ‘UKCA’ (UK Conformity Assessed) mark in the event of a ‘No-Deal’ Brexit. The guidance stated that the UKCA mark would not be recognised on the EU market and manufacturers would still be required to obtain CE marking for products to be placed on the EU market and that the UKCA mark will need to be applied in the following situation(s);

  • The product is for the UK market.
  • The product requires mandatory third-party conformity assessment.
  • The conformity assessment for the product has been carried out by a UK conformity assessment body (a UK-based notified body or recognised third-party organisations).

The guidance also stipulates that “in the majority of cases you will still be able to use the CE marking if you are selling goods on the UK market after the UK leaves the EU. The CE marking will only be accepted in the UK for a limited time after Brexit”, however, this guidance was withdrawn on 30th January 2020.

With the deadline for the end of the 1-year transition period fast approaching, it is still unclear whether the UK government intends to put these measures in place. As a result, manufacturers are urging the UK government to provide more details and guidance on these plans to ensure they have adequate time to prepare to affix the UKCA mark on their products.

It is understood that the UK government is not likely to announce details of the new UKCA mark until a mutual decision has been made as part of the ongoing UK-EU trade negotiations. Understandably, concerns are growing as to the relatively short time left to put any new UK requirements in place to ensure compliance before the end of the year, although we have been made aware from a reliable source that the MHRA is currently reviewing the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

We will keep you posted with any updates as soon as we receive them.

COVID-19| Protective Equipment

Most of the equipment being used as protection against airborne particles and small droplets are covered by specific EU harmonised legislation. The vast majority of these products are classified as Personal Protective Equipment (PPE) and fall under the scope of Regulation (EU) 2016/425. These products are intended to protect the wearer.

Products that are intended to protect the patient, such as medical gloves and medical face masks, will fall under the scope of the Medical Device Directive 93/42/EEC (MDD) (to be replaced by the Medical Device Regulation 2017/745 (MDR)).

Meeting either of the above legislation will allow the manufacturer to legally affix the CE mark and circulate freely in the EU. The essential requirements of the PPE Regulation and the MDD may be met by following harmonised standards, which are published in the Official Journal of the European Union. Following this technical solution, conformity to the essential requirements may be presumed.

The following harmonised standards are applicable to face masks:

FFP-Type [PPE]             EN 149:2001+A1:2009

Medical [MD]                EN 14683:2019+AC:2019

These standards may be obtained through the following link.

The manufacturer is not required to meet all the specifications of these standards and can adopt different technical solutions. However, due to the presumption of conformity, time-to-market may be reduced drastically.

The manufacturer may decide to carry out the tests prescribed in the harmonised standards themselves or outsource this testing to a laboratory. Should the manufacturer follow these standards, the EU Competent Authorities may take a product sample and test these in accordance with the tests prescribed in the standard as part of market surveillance procedures.

Additional technical solutions and guidelines have been compiled in a list by the World Health Organisation. However, in following one of these alternative standards referred to by the WHO for PPE products, the manufacturer shall submit a sample to be tested by a designated notified body. The EU Commission has urged notified bodies to prioritise new requests for COVID-19 related PPE. In a Recommendation issued on 13 March 2020, the Commission encourages notified bodies to adopt derogations which will allow speedier market access under certain conditions.

  • Point 7 of the Recommendation allows manufacturers to anticipate the placement of their products on the market whilst the conformity assessment procedures are being finalised.
  • Point 8 of the Recommendation allows manufacturers to place their products on the market even if no conformity assessment procedures have been initiated.

Under the MDD and the MDR, medical face masks and examination gloves are considered to be class I medical devices, and as such are dependent on self-assessment and will not require notified body intervention. However, if provided in a sterile state, a notified body will be required to assess those aspects of sterility.

On the other hand, face masks and equipment used to protect against COVID-19 and are covered by the PPE Regulation are classified as Category III PPE, and thus a notified body must be involved.

In both cases, PPE and medical devices must be placed on the market with the EU/EC Declaration of Conformity document, as well as the accompanying CE Certificate issued by the notified body, when applicable. No other documents are required for market access, however, there are some additional considerations to keep in mind.

Issuing a Declaration of Conformity (DoC) signifies that you comply with that specific EU Regulation / Directive and that you have met all their requirements. Part of these requirements will be to develop and maintain a set of technical documentation.

Medical devices falling into class I, must be registered with the applicable EU Competent Authority in the country in which the manufacturer or their EU Authorised Representative is based.

For more information on how to lawfully place your PPE or medical devices on the EU market, please do not hesitate to contact us at info@advenamedical.com.

Reusable Surgical Instruments in EU Regulation 2017/745

A Reusable Surgical Instrument is defined as: “an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.” – 2.3, Chapter I, Annex VIII.

It should be noted that only devices without a connection to an active medical device can be defined in this manner, otherwise they will be given a higher classification. Examples of devices falling into this class include:

  • Scalpels and scalpel handles
  • Reamers
  • Drill bits
  • Saws, that are not intended for connection to an active device
  • Retractors, forceps, excavators, and chisels
  • Sternum retractors for transient use.

Considerations in the Medical Device Regulation

Under the current Medical Device Directive, these devices fall under Class I, with no Notified Body (NB) involvement (unless sold sterile). Similarly, the Medical Device Regulation also classifies these devices as Class I, however will now require Notified Body involvement with respect to the following aspects relevant to the reuse of the device:

  • Cleaning
  • Disinfection
  • Sterilisation
  • Maintenance and functional testing
  • Related instructions for use.

In line with point 7 of Article 52 of the MDR, the manufacturer will be required to:

  • Issue a Declaration of Conformity
  • Establish and maintain the technical documentation in accordance with Annexes II and III
  • Apply the procedures laid out in either Chapter I and III of Annex IX, or in Part A of Annex XI.

Conformity assessment with respect to Annex IX will be based on a Quality Management System and on the assessment of technical documentation, whilst a conformity assessment with respect to Annex XI will be based on product conformity verification.

This situation is very similar to that of Class I devices supplied in a sterile condition, or with a measuring function. It is evident that a vital part of conformity with the Regulation will be to provide detailed procedures for the processes involved in preparing the device for reuse. The manufacturer must also supply information on the validated method of re-sterilisation appropriate to the Member State in which the device is placed on the market.

Furthermore, the manufacturer must provide the end-user with information indicating the limitations of reuse so as to maintain device safety and performance. Such information could include the maximum allowable number of reuses, or guidance on how to recognise the signs of material degradation which could indicate that the device is no longer safe to use. Information on the maximum amount of times the device can be reused will eventually need to be provided to the UDI database. In addition to this, it is also required that any traceability, or safety information present on the device should remain legible after every preparation for reuse.

If you require any assistance on bringing your Reusable Surgical Instruments into conformity with the MDR, please do not hesitate to contact us at info@advenamedical.com.

In-Vitro Diagnostic Medical Device Regulation

It would seem like the new IVD Regulation (IVDR) has been behind the scenes, overshadowed by the Medical Device Regulation (MDR). The IVDR brings with it a totally new classification system, which resembles that of medical devices. Previously, IVDs were classified as either general, self-testing, list A or list B devices. In contrast, with this old system, IVDs will now be classified as D, C, B, A, or other, in descending order with respect to the risk posed by the device.

As a snippet of the changes being made in this Regulation, all self-testing IVDs will fall under class C, except for those devices used to detect pregnancy, test for fertility, determine cholesterol levels, and devices which are used for the detection of glucose, erythrocytes, leucocytes, and bacteria in urine, which are classified as class B.

To determine the classification of a device, one must first consult the classification rules (of which there are seven) highlighted in Annex VIII of the new Regulation. Every manufacturer currently following the IVDD should definitely have a look at these new rules, as we are aware that many devices will need to be “up-classed”, and therefore may require Notified Body involvement. If you are an IVD manufacturer and are concerned about what changes the new Regulation may mean to you, please do not hesitate to get in contact with us. We would be able to propose a classification with respect to the IVDR, and also establish which conformity route should be taken.

The commission is currently focussing on establishing both the Medical Device Coordination Group (MDCG) and the EU Reference Laboratories (EURL). The latter are to be established 18 months before the Date of Application (not 6 months as previously thought). Class D devices will be subject to a control by EURLs and may also be subject to a scrutiny mechanism by an expert group.

The MDCG is a proposed group that will investigate assessments of high-risk devices made by Notified Bodies. The group shall be formed of national representatives, and will carry out their investigations prior to the product being placed on the market.

There is also considerable work being done with respect to companion diagnostics. Currently, there’s a lot of focus on molecular profiling, however it is thought that other technologies may also play a vital role: Immunohistochemistry, traditional immunoassays, protein profiling using microarrays, and mass spectrometry. Furthermore, there is a need to review certain elements of companion diagnostic devices, in particular specification.

With Task Groups still looking into vigilance, establishing expert panels and laboratories, it seems like the Regulation is going to be based on rocky foundations as the details of these are still to be determined. It may be that a classification guidance of some sort will be required, since no doubt the new classification system will bring out some borderline devices which are hard to place in one class. We now all await the end of May for the official publication in the EU Official Journal, and watch how all this unfolds.

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