Medical devices – regulatory frameworks

Manufacturers from outside of the EU wishing to export medical devices to the EU need to meet the requirements set out in any applicable EU legislation. As described in Section 2, an important part of this process for many medical devices is conformity assessment before a product can be placed on the market, and audit of the production processes, both carried out by a notified body.

Importers and distributors of medical devices from manufacturers based in third countries must certify that the products comply with EU legislation, which may require certification by a third party conformity assessment body in some circumstances.

Countries can use bilateral Mutual Recognition Agreements (MRAs) which allow conformity assessment bodies in either market to carry out product testing and certification to each other’s legislative requirements. The authorities in both parties agree to accept conformity assessment decisions issued by bodies recognised in one another’s markets. Manufacturers still need to ensure that products meet the requirements set out in the legislation where they plan to market the product. For example, the EU has agreed MRAs for medical devices with Australia, Switzerland and New Zealand.

The EU has concluded MRAs with seven countries, covering a variety of sectors. Some of the EU’s bilateral MRAs have been integrated into Free Trade Agreements (FTAs).One example is the Comprehensive Economic Trade Agreement (CETA), between Canada and the EU, which has identified medical devices as a priority area for mutual recognition of conformity assessment in the future. CETA also contains provisions for voluntary cooperation on data exchange to support market surveillance activity and exchange of information about the development of technical regulations.

Other existing agreements, such as the EU-Swiss agreements and the EEA Agreement, provide for further mutual recognition. For example the EU-Swiss MRAs provide mutual recognition across around twenty product types, including medical devices, and are linked to an agreement that recognises Swiss legislation as equivalent. Where legislation is deemed equivalent, notified bodies’ certificates of conformity with the product rules in the EU will be recognised as proving conformity with Swiss legislation, and vice versa. They also cover cooperation on market surveillance of products already
on sale.

In the EEA agreement, for industrialised goods, EEA countries adopt EU product legislation into their domestic legislation, and goods that originate from these countries are treated as products from Member States. The agreement also includes a system of surveillance and enforcement.

Pharmaceuticals – regulatory frameworks

Manufacturers from outside of the EU wishing to export pharmaceuticals to the EU need to meet the requirements set out in any applicable EU legislation, which is implemented through the EMA as set out in Section 2. This includes having a market authorisationholder, Qualified Person and Qualified Person for pharmacovigilance based in the EU. These individuals, and any importers and distributors, must be satisfied of the safety of medicines and ensure all legislative requirements are fulfilled.

In the area of pharmaceuticals, agreements with third countries to facilitate trade have typically focussed on reducing duplication of regulatory activity during the compliance process, whilst ensuring a high level of protection of public health and patient safety. Through MRAs, as outlined above, the EU has agreed mutual recognition of batch release testing of medicines and mutual recognition of inspection of quality assurance processes (GxP), such as Good Laboratory Practices and Good Manufacturing Practices. For example, the EU-Swiss agreement provided for mutual recognition of batch release testing and GxP inspections; and CETA provides mutual recognition of batch release testing and of certificates of GMP compliance.

In some areas, the development of legislative requirements and agreements is informed by international organisations which facilitate the development of common approaches across countries, drawing on best practice. These organisations bring together national regulators. For example, the OECD adopted the Mutual Acceptance of Data (MAD) to avoid duplicative testing of chemicals to meet regulatory requirements. MAD requires that test data generated in any member country in accordance with OECD Test Guidelines and Principles of Good Laboratory Practice (GLP) shall be accepted in other member countries for assessment purposes and other uses relating to the protection of human health and the environment. The EU has adopted the OECD GLP principles and revised OECD Guides for Compliance Monitoring Procedures for GLP as annexes to two EU GLP Directives, and these underpin the mutual recognition agreements.

In addition, to support pharmacovigilance, the EMA cooperates with regulatory bodies around the world and the EU has specific agreements in place with the USA, Canada, Japan, Switzerland, Australia, New Zealand and Israel that enable this.

Customs

There are many customs facilitation arrangements in international agreements. These include the EU’s agreements with a number of third countries, such as Canada, Korea,and Switzerland. These agreements differ in the depth and scope of customs facilitation offered. Examples of customs facilitations include: simplifying customs procedures,advance electronic submission and processing of information before physical arrival of goods, and mutual recognition of inspections and documents certifying compliance with the other parties’ rules.

Tariffs

In the absence of a preferential trade agreement, goods imported into the EU from nonEU countries must pay tariffs on goods for which tariffs are charged. Tariffs are custom duties levied on imported goods. Under the World Trade Organisation (WTO) Most Favoured Nation (MFN) a country’s tariff schedule must be consistently applied to imports from countries it trades with, except those where a preferential trade agreement exists. EU MFN tariff rates vary depending on the good. The EU’s MFN applied duty is zero for the large majority of medical devices tariff lines.

The Pharmaceutical Tariff Elimination Agreement has meant the elimination of tariffs on thousands of pharmaceutical entities. It includes a commitment to not replace tariff barriers with non-tariff barriers and extends to cover products imported from states not signatory to the Agreement. All finished pharmaceutical products are automatically covered by the Agreement, however, active ingredients and intermediates (used in the manufacture of finished pharmaceuticals) do not automatically qualify for zero tariffs and must be formally added to the list of eligible products.

The EU has agreements with a range of trading partners that amend the tariff rates applied to goods. Where these create tariff preferences for the minority of pharmaceutical products that are not covered by the Agreement, exports must meet a Rule of Origin in order to enjoy that tariff preference.

Rules of origin

The EU includes rules of origin in all of its FTAs, which are restrictions on the originating content of products that exporters must comply with to gain tariff preferences. These rules typically reflect both the supply chains of both the EU and its FTA partner. Many of the EU’s rules of origin arrangements are based on the Regional Convention on PanEuro-Mediterranean Preferential Rules of Origin, which includes provisions that allow producers to treat content from some third countries as if it comes from their own country. Several arrangements aim to reduce the administrative requirements associated with origin certification, including the EU’s Registered Exporter (REX) system, which lets businesses register for self-certification of origin using an online system, avoiding paper certificates.