🤔 CE-Marking Confusion

The UK grace period comes to an end on the 1st January 2022 and I have had numerous conversations regarding Medical Devices to be placed on the UK Market after Brexit by popular demand.

Many manufacturers based in the EU27-market (EU27) face similar scenarios and are scratching their heads nervously.

Common questions are starting to arise and each answer that appears is different. On the surface, much has already been harmonised between the UK and the EU.

Yet, logistic problems persist. Regarding CE-Marking procedures, Brexit certainly has a negative impact.

Some of the guidance issued by authorities has been helpful, while some source material is over-saturated with minor straight-line clarification or well-understood scenarios put forward.

Subsequently, insurmountable confusion is circling the CE-Marking procedure as a result, particularly because of the dependencies of the EU MDR and the UKCA, the UK’s newly polished UK Regulatory Conformity Marking system.

As there is very little of a precise plan or strategy at this point, it’s a matter of interpretation.

The importance of CE-Marking

The EU MDR is a pyramid system with CE-Marking (CE-Marks) sitting at the top.

At the bottom lays a preamble of Definitions, Classifications, Essential Requirements, Clinical Evaluations and Investigations, Conformity Assessments, Quality Management Systems (QMS), Post Market Surveillance Planning (PMS), Post-market Clinical Follow Up (PMCF) schemes.

Nevertheless, all Medical Devices to be distributed and sold throughout the EU market must be CE-Marked.

What does CE-Marking constitute?

• Class I Devices: CE mark only (except Class Im- Is)
• Higher Classes: require CE mark + Notified Body number.
• General category IVDs: need CE mark only.
• Higher risk IVDs: require CE mark + Notified Body number.

1-way & 2-way Binding CE Marking Procedures

CE Marking will longer be recognised for British manufactured Medical Devices placed on the EU27 after 31st December 2021 and must be certified by EU27 Notified Bodies (NB).

Reacting to the challenge of Brexit, many UK CE-Marking registrators and assessors have now been outsourced to the EU as the UK will introduce the UKCA.

Transferring operations makes sense for those who can afford to do so, and possessing responsible NBs based in the EU27 to help keep processes fluid until the end of the UK Government’s grace period (1st January 2022) is wise.

Interestingly, Lloyds Register Quality Assurance Ltd (LRQA) has ceased operations and remain pending until further notice. SGS United Kingdom Limited has now outsourced operations to Belgium for the foreseeable future. UL International (UK) Ltd has outsourced operations to PCBC Poland, and BSI Assurance UK Ltd likewise to BSI Netherlands.

UK AR vs EC REP

For now, the UK Government has agreed that for manufacturers wishing to supply goods into the UK, the CE-Mark, including the results of Conformity Assessments performed by a EU27 Notified Body, will continue to be recognised until 1st January 2022.

This grace period does not extend to EU27 products that require either mandatory or regular involvement of an NB based in the UK to be distributed and sold in the UK Market.

There are various ways of interpreting such information.

One would think this regards Medical Devices which have significant impacts on the safety of the users or if the Medical Device in question has complicated risk factors due to its compatibility and interoperability with other Medical Devices.

Additionally, the risk factor may be more significant for products with modular architectures leveraging Off-the-Shelf (OTS) or self-developed Software solutions.

Both use-cases would to a certain degree, require regular assessments or involvement from NB.

Under these circumstances, the product CE-Mark will, by default, become UKCA certificates, and the UKCA mark must be placed on the product immediately and by way of the EU27 manufacturer of the product or an authorised UKCA representative located in a EU27 member state.

Likewise, suppose British manufacturers want to place products onto the EU27. In this case, if a manufacturer who usually places devices on the market under its manufacturing name does not have a registered place of business in a EU27 member state, they will need to designate a single Authorised Representative (AR) in the European Union (EC REP).

The SGS has labelled this operation as a ‘Transfer of Responsibility’. A manufacturer or organisation can apply for the responsibility for the product certification process to be transferred to a EU27 member state NB.

As expected, the proposed submissions from the UKCA have faced some backbite from within the EU. Any UK based ARs not located in a EU27 member state will no longer be recognised as an Economic Operator.

Such transformation has caused nightmares for distributors who now find themselves crisscrossed across and in continuous liaison with the UKCA.

The advice issued so far is confined but relatively straightforward. Manufacturers and distributors with a UK NB or UK AR must confirm they have a EU27 NB or AR designated before placing their products onto the EU27 market.

For UK manufactured devices already placed on the EU27 market, expect little impact, but this may be subject to change after the UK Government’s grace period.

The same goes for devices currently being manufactured or in the middle of production before the Brexit Withdrawal date of 31st January 2020.

Application of the UKCA Mark

The rules governing the use and application of the UKCA mark are not dissimilar to those that apply to the pre-existing CE Mark.

The mark may only be applied to products according to the manufacturer’s specific regulations, or their authorised representative apply to that product.

Further, the mark must not be applied to any product that does not fall within the scope of at least one regulation that requires the mark’s application.

Using the UKCA mark, the manufacturer (or the authorised representative) is responsible for the product’s compliance with all applicable legislation. In specific contexts, legislation may involve harmonising standards from the MDR with existing UK standards, now recognised as UK “Designated Standards”.

It would be wise for organisations or manufacturers to factor this upfront to ensure this does not run directly against distribution and delivery pipelines.

To place products on both markets, manufacturers may choose to mark both the CE and UKCA marks on a product as long as the product is compliant with both UK and EU standards. Once again, this point still requires clarification as to how this can be done effectively.

Application of the Conformity Assessment

Arguably, the most significant disruption for manufacturers in the UK and EU27 is the disruption caused to Conformity Assessments.

Although UK Certified Bodies (CB) or NBs would have been recognised as EU27 NBs operationally and legally before the Brexit Withdrawal agreement, ever since it has become fragmented and somewhat blurry on what is required regarding Conformity Assessment submissions.

Except for Northern Ireland, Conformity Assessment certifications, including Type Examination Certificates issued by a UK NB before the Brexit Withdrawal date, will cease to be valid as a means of demonstrating conformity beyond 1st January 2022.

Similarly, EU27 NB certificates would cease to be acceptable to demonstrate conformity under UK Regulations and subject to the grace period 1st January 2022.

Putting this all together, organisations and manufacturers will need to adopt a “re-registration” plan. The plan should cover multiple integration points into the UK market or EU27 with different scenarios outlined and the required actions covered.

What can one do to reduce overhead?

The extent of Brexit and its impact after 1st January 2022 will vary depending upon the nature of the product in question, although the changes should be primarily administrative. What is definite is new or existing products will need to have their CE-Marking re-evaluated.

The changes will be minimal for those products subject to a self-declaration by a manufacturer.

The Essential Requirements of the MDR are expected to mirror the Essential Requirements of the UK “Designated Standards”. This makes life easier but only just. For UK manufacturers or organisations, they must ensure the DoC for the Medical Device is signed by a UK AR or EU REP located in an EU Member state.

For EU27 manufacturers and organisations, the first sensible approach would be to identify the essential Medical Devices that need to be allocated and anchor down their distribution plans.

From here, identify devices already certified by UK NBs or currently sourced and distributed in the UK. Once all the desired Medical Devices are arranged, engage with UK customs or NBs to enact a Brexit Contingency Plan.

Ideally, this has already been established before May 2021’s new MDR revisions are released.

What makes operations manageable for the time being is recognising both CE-Marks and UKCA Marks on products.

But difficulties may emerge for products or Medical Devices which require continuous assessment by NBs, and therefore, no standardised routine may be applicable.