Guidance

Virtual manufacturing of medical devices

Updated 1 July 2023

Version 3.0

January 2021

Revision history

Version 3

January 2021

To bring it into line with the UK Medical Devices Regulations following the end of the transition period on 31 December 2020

Version 2

April 2019

Section 1 – updated

Section 2 - updated

Section 3 – updated

Section 4 – updated

Section 5 – updated

Section 7 – new section added

Section 8 –used to be section 7. email updated

Section 9 – added to cover distribution

Version 1

March 2017

Changes: n/a

1. Overview

This document, which has been updated to reflect the changes brought about as a result of the transition period with the EU ending, supersedes the previous edition of the guidance.

The government has extended acceptance of CE marked medical devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.

2. What has changed

Two new product markings, the UKCA mark (which is valid in Great Britain) and the CE UKNI marking (which is required in Northern Ireland where conformity assessment has been conducted by a UK Notified Body) have been introduced for certain goods, including medical devices, being placed on the UK market.

The MHRA can designate UK Approved Bodies to conduct assessments against the relevant requirements for the purpose of the UKCA mark. CE-marked medical devices continue to be accepted on the Great Britain market with the deadline for acceptance depending on the type of device and the legislation it complies with. The latest of these deadlines is 30 June 2030. Separate rules exist for Great Britain and Northern Ireland.

For further information, refer to our guidance. The text in this document has been updated to reflect these changes.

3. What is a virtual manufacturer

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. By placing their own name and address on the product, the virtual manufacturer takes on the legal responsibilities for the medical device and is therefore regarded as the manufacturer in accordance with the UK Medical Device Regulations 2002 (SI 2002 No 618, as amended).

Note that in practice there is no difference in the regulatory requirements applying to a manufacturer and a virtual manufacturer.

4. Responsibilities of a virtual manufacturer

Where UK Approved Body (in this document please read as UK Notified Body for the purposes of the Northern Ireland market)/EU Notified Body certification is required, the virtual manufacturer must have a quality management system that will be audited by their UK Approved Body/EU Notified Body. In addition, virtual manufacturers are expected to hold the full technical documentation for the device, which may also be reviewed by their UK Approved Body/EU Notified Body. Virtual manufacturers of medical devices that don’t need UK Approved Body/EU Notified Body approval are still required to hold the full technical documentation for their medical devices, which may be examined by the MHRA. Virtual manufacturers are also required to register their devices with the MHRA.

UK Approved Bodies/EU Notified Bodies should note that manufacturers:

(a) have to fulfil their obligations themselves regardless of any partial or total outsourcing of the production via subcontractors or suppliers;

(b) do not fulfil their obligation to have at their disposal the full technical documentation and/or of a quality system by referring to the technical documentation of a subcontractor or supplier and/or to their quality system;

(c) should integrate the quality system of critical subcontractors and of crucial suppliers with their quality system;

(d) need to control the quality of services provided and of components supplied and the quality of production thereof regardless of the length of the contractual chain between the manufacturer and the subcontractor or supplier.

The virtual manufacturer is also required to sign a Declaration of Conformity that the devices concerned meet the requirements of the applicable device legislation.

Note: All virtual manufacturers, including those manufacturing Class I medical devices and General IVDs, are required to comply with the revised requirements.

5. The technical documentation a virtual manufacturer needs

All manufacturers are expected to hold full technical documentation in order to demonstrate that the medical device that they place on the market, under their own name, meets the regulatory requirements.

The technical documentation should be fully integrated into the manufacturer’s quality management system where applicable and should contain data relevant to the manufacturer (e.g. labels, instructions for use, risk assessment etc.)

Where the virtual manufacturer does not hold the rights related to product design, the UK Approved Body/EU Notified Body and the MHRA may accept a technical file from the virtual manufacturer that has redacted proprietary information as long as the redacted information is not essential for the purposes of the UK Approved Body/EU Notified Body or the MHRA assessing whether the medical device complies with the regulatory requirements. Redactions should be as limited as possible.

In cases where the virtual manufacturer holds redacted technical documentation, they must have contractual arrangements to ensure full disclosure of all applicable information by the original equipment manufacturer (OEM) directly to the UK Approved Body/EU Notified Body of the virtual manufacturer (without the further need for agreements to be put in place between the UK Approved Body/EU Notified Body and the third-party OEM).

The following may constitute proprietary information:

(a) unique material formulae or ingredients which are specific to the medical device and not in general use which are of high commercial and intellectual benefit to the OEM

(b) unique manufacturing processes which have been designed by the OEM and give them a competitive advantage in the marketplace

(c) technical drawings and technologies (applicable where a patent is also being applied for) but not yet granted

(d) software algorithms

Note: Full redaction of all formulas, ingredients, algorithms or manufacturing processes cannot be accepted. Where redactions are made, the justification for these redactions by the OEM must be documented and the top-level information provided should be sufficient to understand the medical device and any associated risks.

Any technical documentation provided to a UK Approved Body/EU Notified Body should include a statement drawn up by the virtual manufacturer indicating they fully understand all the documentation provided and that they accept full legal responsibility.

6. What the contractual agreement between both parties should cover as a minimum

Virtual manufacturers will need to ensure an appropriate contract is in place with the OEM. As a minimum, the contractual agreement should contain the following:

(a) A direct link between the medical devices being placed on the market by the manufacturer that holds the rights to the product design and the virtual manufacturer they are supplying who does not hold the design rights (e.g. by name / part number).

(b) Arrangements for post-market surveillance and vigilance activities (i.e. details of who is responsible for what in relation to these requirements, including reporting of adverse incidents). All virtual manufacturers should ensure that incidents or potential incidents are reported and also brought to the attention of the manufacturer that holds the rights to the product design. Similarly, the manufacturer is responsible for notifying the virtual manufacturer to enable them to take appropriate action with regard to their own products.

(c) Provisions for post-production follow-up, including ensuring that post-market clinical follow-up provisions are in place.

(d) Arrangements for details of any changes to the medical devices to be notified to both parties, with documented approval granted by the OEM where the virtual manufacturer wish to make changes.

(e) Provisions for unannounced audits – i.e. the UK Approved Body/EU Notified Body of the virtual manufacturer will be required to have access to any critical suppliers (including the manufacturer who holds the rights to the design).

(f) The contract should include the fact that the virtual manufacturer may not enter into another contract with another virtual manufacturer for the same device, i.e. a virtual manufacturer cannot be the OEM for another virtual manufacturer for the same medical device.

(g) Provision for the OEM (including the manufacturer who holds the rights to the design) to provide fully un-redacted information upon request of the UK Approved Body/EU Notified Body of the virtual manufacturer, without the requirement for further contractual actions between the UK Approved Body/EU Notified Body and critical supplier such as non-disclosure agreements.

(h) Provision for the OEM, where relevant, to maintain and provide to the virtual manufacturer UK Approved Body/EU Notified Body certification covering the products concerned.

(i) Provision for the OEM, where relevant, to maintain and provide to the virtual manufacturer evidence of registration with their regulator/competent authority.

7. What options a virtual manufacturer has if their OEM loses their UKCA/CE/CE UKNI certificate

(a) obtain evidence of the suspension/withdrawal of the certificate

(b) consider whether there is a safety concern and any impact on the virtual manufacturer’s own certificate and products on the market

(c) understand what arrangement (if any) the OEM is under with their regulator/competent authority

(d) consider using the OEM as a critical supplier to allow continued supply of the virtual manufacturer’s product

(e) inform their UK Approved Body/EU Notified Body immediately of the loss of the OEM’s certificate

8. How disputes with UK Approved Bodies/EU Notified Bodies should be handled

If there is a dispute between a UK Approved Body/EU Notified Body and a virtual manufacturer regarding the regulatory requirements, contact the MHRA for clarification by email [email protected].

9. If a virtual manufacturer wants to change from being the legal manufacturer to the importer/distributor

In Great Britain, a virtual manufacturer will be considered an importer/distributor and not the manufacturer in the following situations where they:

(a) provide a translation into English of the information supplied by the manufacturer for the purpose of making the product available in Great Britain (without affecting the integrity and detail of the information provided by the manufacturer). The manufacturer must have a process to verify that all translations are fit for purpose prior to authorisation

(b) change the size and/or presentation of the outer packaging of a device that has already been placed on the market without affecting the integrity of the device itself

(c) affix their brand name or trademark on the labelling with the agreement of the manufacturer and the manufacturer is identified on the labelling and packaging

(d) stipulate clearly who the device is ‘imported/distributed by’ and ‘manufactured by’ on the packaging and labelling

(e) do not change the intended purpose of the device or modify the device or its packaging in such a way that its compliance with the legislation is affected.

In order to be considered as the importer/distributor there would need to be signed agreement with the manufacturer. The manufacturer’s name must be visible as the legal manufacturer on the packaging and labelling. These details should be easy to read. There is the option for the importer/distributor to be identified on the packaging and labelling with the term ‘imported/distributed by’.

Separate rules will apply in Northern Ireland due to the application of the EU Medical Devices Regulations (2017/745) and in vitro Diagnostic Medical Devices Regulations (2017/746). For further information please see our guidance.