Brexit making headlines again - What is the impact for Medtech companies market access to the EU?
Manufacturing medical devices and diagnostics in the UK? Don’t be out of compliance…
With Brexit making headlines again due the UK not extending the transition time with the EU, UK manufacturers face a tense time.Without a deal by the end of the year, UK medical device and diagnostic manufacturers may be locked out of the EU markets as the UK becomes a third-country in the eyes of the EU. Currently, under the Medical Device Directive (MDD), a manufacturer exporting their products from a country outside of the EU into any country in the EU, is required to have a legal agreement with an Authorised Representative (AR) who is a legal person based in the EU. The main duties of an authorised representative under the MDD, has been to act as a communication channel between the manufacturer and competent authorities such as the MHRA, HPRA etc. Presently, any person can be designated an AR under the MDD as long as they are based in the EU.
However, with the introduction of MDR in May 2021, not just anyone will be able to shoulder the responsibility of being an AR and manufacturers will have to think carefully who will be available to be their AR’s in the coming months due to the shared liability between the EU Authorised Representative and the manufacturer for defective products.
Responsibilities of the Authorised Representative
As per Article 11 of the MDR, the manufacturer and the AR should agree the specific tasks in a mandate which the AR will undertake on behalf of the manufacturer. The AR is obliged to undertake certain compliance tasks which he or she cannot delegate or outsource such as:
- Verify that the manufacture’s device has undergone the appropriate conformity assessment;
- Ensure that the Declaration of Conformity and the technical documentation has been completed;
- Keep a copy of the Declaration of Conformity and the technical documentation along with a copy of the device certificate including supplements and amendments for a suitable time;
- Ensure that the details of the manufacturer, AR, importer and distributor are uploaded to an electronic system and kept up to date;
- Provide Competent Authorities with any information or documentation required to demonstrate that the device meets conformity;
- Forward any requests to the manufacturer from the Competent Authorities for sample devices;
- Cooperate with Competent Authorities on any corrective or preventative actions;
- Immediately inform the manufacturer of any complaints or complaints related to their devices;
- Terminate their mandate as AR if the manufacturer acts contrary to the MDR.
While the AR is responsible for ensuring that the manufacturer is compliant, if this is not the case then the AR is equally liable as the manufacturer for any defective devices if the manufacturer has not met their obligations as per Article 10 of the MDR. Therefore, the role of an AR is not simply a placeholder but someone who must be active in ensuring that the manufacturer is fulfilling its obligations and that defective product is not placed on the market.
Manufacturers outside of the EU including the UK, will discover that it will take far longer for an AR to sign a mandate between them as extensive due diligence will be required. This due diligence could take extensive and will be required before any contract can be entered into. For manufacturers who have not started their search for their qualified AR, it is imperative to start now as their companies’ risk being unable to supply their importers and distributors with legal product come May 2020. Taking early steps to ensure that all these requirements are met will ease the burden on manufacturers and ensure that their product stays on the market legally. Failure to do so will leave their competitors to swallow their market share.
If your company is affected by Brexit or looking for access to the EU market, Med-Di-Dia are willing to listen and support your products on the market. Med-Di-Dia is a regulatory and quality compliance consultancy firm supporting Medical Device, In-Vitro Diagnostic and Digital Healthcare companies from our base in Galway, Ireland. We offer a range of services under the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR), including EU Authorised Representative, for companies placing their products on the European market from small start-ups to multinationals. Contact us at email@example.com.